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RecruitingNCT05704829ADAPTHER2-IVUpdated Jun 9, 2026

NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

A Phase 2 interventional study of Trastuzumab deruxtecan and Standard-of-Care in HER2-positive Early Breast Cancer, sponsored by West German Study Group. Recruiting at 44 sites in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by West German Study Group · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
702
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC.

ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).

Read the detailed description

As the ADAPT-trials have clearly shown, pCR after 12 weeks of therapy, independent of the specific de-escalated neoadjuvant regimen and independent of further use of systemic chemotherapy, is an independent predictor of excellent prognosis4,19, also in patients treated by an antibody-drug conjugate alone (T-DM1), or in those receiving pertuzumab+trastuzumab+/-weekly paclitaxel.

In contrast to the adjuvant setting, none of the neoadjuvant trials so far has focused on HER2+ patients with a low-intermediate risk profile (e.g., node-negative patients with cT1-2 tumours). The ADAPT-HER2-IV trial aims to close this evidence gap.

Since there is some uncertainty about the optimal treatment duration in intermediate- to high-risk HER2+ EBC (e.g., tumour size >3 cm), we recommend using a longer 18-week taxane-based treatment (+/- carboplatin, at investigator´s decision) due to a large body of evidence for taxane + carboplatin combinations in patients in locally advanced stages.

Antibody-drug conjugates appear to be ideal candidate drugs for a "de-escalated" treatment due to their favourable safety (reduced alopecia, polyneuropathy rates, etc.) and a high efficacy profile (e.g., comparable pCR rates after 18 weeks of T-DM1 and taxane+pertuzumab+trastuzumab in the PREDIX HER2 trial20). Similarly to the classical chemotherapy landscape, optimal duration of antibody-drug conjugate-based neoadjuvant therapy remains unclear. pCR rates of around 40% to 60% were observed after 12 and 18 weeks of T-DM1 treatment (+/-pertuzumab) in the ADAPT TP, KRISTINE and PREDIX HER2 trials in HR+/HER2+ disease21,22. Moreover, long-term survival seem to be comparable between T-DM1+pertuzumab and older chemotherapy-containing regimens (docetaxel+carboplatin+trastuzumab+pertuzumab) despite of higher local progression rates and lower pCR in one study22.

Trastuzumab-deruxtecan (T-DXd) has shown promising activity in a small cohort of metastatic patients, including both HER2+ and HER2-low BC, pre-treated with several lines of therapy. Doi et al. reported overall response rates (ORR) of 58% and a disease control rate of 100% with overall survival at 12 months at in HER2+ disease pre-treated by T-DM1+/-pertuzumab in a late line setting23. T-DXd-therapy was associated with a manageable safety profile. Recently, clearly higher efficacy of T-DXd vs. T-DM1 was shown in second line metastatic breast cancer (MBC) in the DESTINY-03 trial24. Median progression free survival was not reached in T-DM1-arm vs. 6.8 months in the T-DXd-arm. This effect was independent of hormone receptor status, prior pertuzumab treatment, visceral metastases, number of prior therapy lines and presence of brain metastases. ORR was doubled (34.2 vs. 79.7%), favouring the T-DXd arm.

02

Conditions studied

  • HER2-positive Early Breast Cancer

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Keywords

  • HER2+
  • T-DXd
  • Trastuzumab-deruxtecan
  • pCR
  • intermediate risk
  • high risk
  • low risk
  • recurrence
  • neoadjuvant
03

In context

Recurrence

4,278 studies on the registry are indexed under Recurrence; 990 are open to participants now.

This study's planned enrollment of 702 is above the median of 50 across 3,373 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

West German Study Group is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

Patients eligible for inclusion in this study must meet all the following criteria:

1. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO guidelines) 2. Age ≥18 years 3a. Cohort 1: low- to intermediate-risk for recurrence as per investigator´s decision (recommendation: cT1c - cT2 (1 - ≤3cm) AND cN0; cT1a/b, cN0 excluded), OR 3b. Cohort 2: intermediate- to high-risk for recurrence as per investigator´s decision (recommendation: cT2 (>3 - ≤5cm), cN0) 3c. Cohort 3: intermediate- to high-risk for recurrence as per investigator´s decision, (recommendation: clinical stage II (cT2, cN0); cT1c, cN0 only if neoadjuvant treatment intended) 4. Written informed consent 5. LVEF ≥ 50% within 28 days before randomisation 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 7. Adequate bone marrow and organ function within 14 days before randomisation as defined by the following laboratory values:

  • absolute neutrophil count ≥ 1.5 × 109/L,
  • platelets ≥ 100 × 109/L,
  • haemoglobin ≥ 9.0 g/dL:
  • estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula,
  • INR ≤ 1.5,
  • serum creatinine \< 1.5 mg/dL,
  • total bilirubin \< ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN,
  • aspartate transaminase (AST) \< 2.5 × ULN,
  • alanine transaminase (ALT) \< 2.5 × ULN. 8. Adequate treatment washout period before randomisation (refer to protocol for detailed information) 9. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential (refer to protocol for detailed information) Post-menopausal status is accepted for women, who at the time of initiation of study medication, either
  • had underwent bilateral oophorectomy, or
  • are ≥ 60 years of age, or
  • are \< 60 years of age and amenorrhoeic for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression)

  • and/or whose FSH- and oestradiol-blood values are within the postmenopausal range per local laboratory normal range.

    10. Female subjects must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration.

Exclusion criteria

Exclusion Criteria:

Patients eligible for inclusion in this study must not meet any of the following criteria:

  1. 1. Non-operable breast cancer including inflammatory breast cancer
  2. cT1a/b, cN0 breast cancer
  3. Any previous history of invasive breast cancer

  4. Primary malignancies within 5 years, with the exception of

    • adequately resected non-melanoma skin cancer
    • curatively treated in-situ disease
  5. Any evidence for existing metastatic disease (confirmed by CT Thorax/Abdomen, bone scan, or other methods according to clinical practice
  6. Previous or concurrent treatment with cytotoxic agents for any reason (except non-oncological reasons)
  7. Concurrent treatment with other experimental drugs and participation in another clinical trial with any investigational drug within 30 days prior to study entry
  8. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study/inadequate organ function
  9. Reasons indicating risk of poor compliance
  10. Woman of child-bearing potential defined as a woman physiologically capable of becoming pregnant, and not using highly effective methods of contraception during the study treatment and for 7 months after stopping the treatment.
  11. Use of oral (oestrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.
  12. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
  13. Patients with a medical history of myocardial infarction (MI) within 6 months before randomisation, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrolment to rule out MI.
  14. Corrected QT interval (QTcF) prolongation to > 470 msec (females) based on average of the screening 12-lead ECG.
  15. History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

  16. Lung criteria:

    • Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder
    • Any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of randomisation.
    • Prior pneumonectomy (complete)
    • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  17. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC).

  18. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan or carboplatin.

    Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP.

  19. Known allergy or hypersensitivity to study treatment (T-DXd), to comparator (SoC-) treatment, or any of the study drug / comparator (SoC-) excipients.
  20. History of severe hypersensitivity reactions to other monoclonal antibodies.
  21. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
702 participants (estimated)

Study arms

  • Experimental
    T-DXd 12 weeks: HER2+ and low-intermediate risk for recurrence

    12 weeks T-DXd i.v. in neoadjuvant treatment; pCR dependent T-DXd for 1 year in total in postneoadjuvant treatment

    Drug: Trastuzumab deruxtecan

  • Experimental
    T-DXd 18 weeks: HER2+ and intermediate-high risk for recurrence

    18 weeks T-DXd i.v. in neoadjuvant treatment; pCR dependent T-DXd for 1 year in total in postneoadjuvant treatment

    Drug: Trastuzumab deruxtecan

  • Other
    Control SoC CTx 12 weeks: HER2+ and low-intermediate risk for recurrence

    Standard-of-Care-Treatment: 12 weeks PAC+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment

    Drug: Standard-of-Care

  • Other
    Control SoC CTx 18 weeks: HER2+ and intermediate-high risk for recurrence

    Standard-of-Care-Treatment: 18 weeks PAC/DOC+Carbo+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment

    Drug: Standard-of-Care

  • Experimental
    T-DXd 12 weeks + SoC CTx 6 weeks

    12 weeks T-DXd i.v. follwed by 6 weeks SoC chemotherapy in neoadjuvant treatment; pCR dependent postneoadjuvant treatment: * non-pCR: 14 cycles of T-DXd is strongly recommended or SoC treatment, i.e., chemotherapy and anti-HER2-treatment, including T-DM1 at investigator´s decision * pCR: SoC treatment, e.g., T +/- P or T-DM1 (at investigator´s decision)

    Drug: Trastuzumab deruxtecan · Drug: Standard-of-Care

  • Experimental
    T-DXd 12 weeks + SoC CTx 12 weeks

    12 weeks T-DXd i.v. follwed by 12 weeks SoC chemotherapy in neoadjuvant treatment; pCR dependent postneoadjuvant treatment: * non-pCR: 14 cycles of T-DXd is strongly recommended or SoC treatment, i.e., chemotherapy and anti-HER2-treatment, including T-DM1 at investigator´s decision * pCR: SoC treatment, e.g., T +/- P or T-DM1 (at investigator´s decision) Therapy for patients with non-pCR who received neoadjuvant T-DXd (12 weeks) + 12 weeks (4 cycles) of SoC chemotherapy will exceed total therapy over one year. Here, approximately 66 weeks are considered as maximum therapy (individual variations may apply)

    Drug: Trastuzumab deruxtecan · Drug: Standard-of-Care

  • Other
    SoC CTx 18 weeks

    Standard-of-Care-Treatment: 18 weeks PAC/DOC+Carbo+T+P (standard-of-care) in neoadjuvant treatment; pCR dependent SOC chemotherapy +T+/-P or SOC T+/-P for 1 year in total in postneoadjuvant treatment * non-pCR (in particular ypT \>1b (5 mm) or ypN+: 14 cycles with T-DXd recommended * pCR: SoC treatment, e.g., T +/- P or T-DM1 (at investigator´s decision) Therapy for patients with non-pCR who received neoadjuvant SoC chemotherapy will exceed total therapy over one year. Here, approximately 60 weeks are considered as maximum therapy (individual variations may apply).

    Drug: Standard-of-Care

Interventions

  • DrugTrastuzumab deruxtecan

    T-DXd i.v.

    Also known as: ENHERTU

  • DrugStandard-of-Care

    Chemotherapy+T+P

    Also known as: Chemotherapy+T+P

06

What researchers measure

Primary outcomes

  1. Adverse drug reactions with CTCAE-grade 3 or higher, compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks of neoadjuvant treatment

  2. distant disease-free survival (dDFS, according to STEEP 2.0 criteria): T-DXd

    dDFS in patients with T-DXd neoadjuvant monotherapy (pooled experimental treatment arms of part 1, pooled cohorts 1 and 2)

    Time frame: after 3 years

  3. distant disease-free survival (dDFS, according to STEEP 2.0 criteria): CTx

    in patients with T-DXd neoadjuvant therapy followed by CHT (pooled experimental treatment arms of part 2, cohort 3)

    Time frame: after 3 years

  4. pCR rate after neoadjuvant treatment

    defined as ypT0is/ypN0, compared between patients treated with T-DXd neoadjuvant monotherapy (pooled experimental treatment arms of part 1, pooled cohorts 1 and 2) compared to patients of corresponding standard-of-care treatments (DOC/PAC+T+P or DOC/PAC+Carbo+T+P) (pooled standard-of-care treatment arms of part 1, pooled cohorts 1 and 2)

    Time frame: after 18 weeks of neoadjuvant treatment

Secondary outcomes

  1. distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 18 weeks

    compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 3 years

  2. distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 12 weeks

    compared between patients treated with T-DXd neoadjuvant monotherapy for 12 weeks (part 1, cohort 1) and patients treated with SoC for 12 weeks (part 1, cohort 1) 2 and 3 pooled)

    Time frame: after 3 years

  3. distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 12 plus 6 weeks

    compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 6 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 3 years

  4. distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 12 plus 12 weeks

    compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 12 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 3 years

  5. distant disease-free survival (dDFS, according to STEEP 2.0 criteria)

    in patients with pCR after neoadjuvant treatment without further chemotherapy: It should be tested whether 3-year dDFS of each arm exceeds 92% (literature data)

    Time frame: after 3 years

  6. pCR rate: 18 weeks

    defined as ypTis/ypN0 in patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

  7. pCR rate: 12 weeks

    defined as ypTis/ypN0 in patients treated with T-DXd neoadjuvant monotherapy for 12 weeks (part 1, cohort 1) and patients treated with SoC for 12 weeks (part 1, cohort 1)

    Time frame: after 12 weeks treatment

  8. pCR rate: 12 plus 12 weeks

    defined as ypTis/ypN0 in patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 12 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 24 weeks treatment

  9. Clinical response after 6 weeks

    defined as either cCR, cPR, cSD, after 6 weeks of neoadjuvant treatment compared between T-DXd treated patients and SoC treated patients

    Time frame: after 6 weeks treatment

  10. Clinical response after 12 weeks

    defined as either cCR, cPR, cSD, after 12 weeks of neoadjuvant treatment compared between T-DXd treated patients and SoC treated patients

    Time frame: after 12 weeks treatment

  11. Clinical response after 24 weeks

    defined as either cCR, cPR, cSD, after 24 weeks of neoadjuvant treatment compared between T-DXd treated patients and SoC treated patients

    Time frame: after 24 weeks treatment

  12. iDFS

    survival endpoint STEEP 2.0

    Time frame: at end of study

  13. OS

    survival endpoint STEEP 2.0

    Time frame: at end of study

  14. LRFS

    survival endpoint STEEP 2.0

    Time frame: at end of study

  15. BCFS

    survival endpoint STEEP 2.0

    Time frame: at end of study

  16. DRFI

    survival endpoint STEEP 2.0

    Time frame: at end of study

  17. QOL

    health-related quality of life

    Time frame: after 1 year

  18. adverse drug reaction with CTCAE-grade 3 or higher: 12 weeks mono

    Number of ADR with CTCAE-grade 3 or higher in patients treated with T-DXd neoadjuvant monotherapy for 12 weeks (part 1, cohort 1) and patients treated with SoC for 12 weeks (part 1, cohort 1)

    Time frame: after 12 weeks treatment

  19. adverse drug reaction with CTCAE-grade 3 or higher: 18 weeks combined

    Number of ADR with CTCAE-grade 3 or higher in patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 6 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

  20. adverse drug reaction with CTCAE-grade 3 or higher: 24 weeks combined

    Number of ADR with CTCAE-grade 3 or higher in patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 12 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 24 weeks treatment

  21. Proportion of patients with any TEAE: 18 weeks mono

    compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

  22. Proportion of patients with any TEAE: 12 weeks mono

    compared between patients treated with T-DXd neoadjuvant monotherapy for 12 weeks (part 1, cohort 1 ) and patients treated with SoC for 12 weeks (part 1, cohort 1)

    Time frame: after 12 weeks treatment

  23. Proportion of patients with any TEAE: 18 weeks combined

    compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 6 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

  24. Proportion of patients with any TEAE: 24 weeks combined

    compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 12 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 24 weeks treatment

  25. Frequency of TEAE: 12 weeks

    in all T-DXd based neoadjuvant treatment regimens as well as in SoC for 12 weeks (part 1, cohort 1)

    Time frame: after 12 weeks treatment

  26. Frequency of TEAE : 18 weeks

    in all T-DXd based neoadjuvant treatment regimens as well as in SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

  27. Proportion of patients with adverse event of special interest (AESI): 18 weeks mono

    AESI) (interstitial lung disease, QT time prolongation, LVEF decrease, infusion related reactions) compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

  28. Proportion of patients with adverse event of special interest (AESI): 12 weeks mono

    AESI) (interstitial lung disease, QT time prolongation, LVEF decrease, infusion related reactions) compared between patients treated with T-DXd neoadjuvant monotherapy for 12 weeks (part 1, cohort 1 ) and patients treated with SoC for 12 weeks (part 1, cohort1 )

    Time frame: after 12 weeks treatment

  29. Proportion of patients with adverse event of special interest (AESI): 18 weeks combined

    AESI) (interstitial lung disease, QT time prolongation, LVEF decrease, infusion related reactions) compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 6 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

  30. Proportion of patients with adverse event of special interest (AESI): 24 weeks combined

    AESI) (interstitial lung disease, QT time prolongation, LVEF decrease, infusion related reactions) compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 12 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 24 weeks treatment

  31. Frequency of AESI in T-DXd

    in all four T-DXd based neoadjuvant treatment regimens

    Time frame: after 12 weeks treatment

  32. Frequency of AESI in SoC: 12 weeks

    in SoC for 12 weeks (part 1, cohort 1)

    Time frame: after 12 weeks treatment

  33. Frequency of AESI in SoC: 18 weeks

    in SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

    Time frame: after 18 weeks treatment

07

Study locations

40 of 44 sites recruiting
  • Klinikum Mittelbaden, Brustzentrum
    Baden-Baden, Baden-Wurttemberg 76532, Germany
    • Antje Hahn, Dr. · Contact
    • Anje Hahn, Dr. · Principal investigator
    • Uwe Cramer, Dr. · Sub investigator
    Recruiting
  • Praxis für Interdisziplinäre Onkologie und Hämatologie (PIO)
    Freiburg im Breisgau, Baden-Wurttemberg 79110, Germany
    • Matthias Zaiss, Dr. · Contact
    • Matthias Zaiss, Dr. · Principal investigator
    • Alexander Völkel, Dr. · Sub investigator
    Recruiting
  • Universitätsklinikum Tübingen
    Tübingen, Baden-Wurttemberg 72076, Germany
    • Andreas Hartkopf, Prof. Dr. · Contact
    • Andreas Hartkopf, Prof. Dr. · Principal investigator
    • Tobias Engler, Dr. · Sub investigator
    Recruiting
  • Universitätsklinikum Ulm
    Ulm, Baden-Wurttemberg 89075, Germany
    • Brigitte Rack, Prof. Dr. · Contact
    • Brigitte Rack, Prof. Dr. · Principal investigator
    • Angelina Fink, Dr. · Sub investigator
    Recruiting
  • Hämotologisch onkologische Praxis Heinrich Bangerter Augsburg GbR
    Augsburg, Bavaria 86150, Germany
    • Bernhard Heinrich, Dr. · Contact
    • Bernhard Heinrich, Dr. · Principal investigator
    • Markus Bangerter, Prof. Dr. · Sub investigator
    Recruiting
  • Universitätsklinikum Augsburg / Klinik für Frauenheilkunde und Geburtshilfe
    Augsburg, Bavaria 86156, Germany
    • Nina Ditsch, Prof. Dr. · Contact
    • Nina Ditsch, Prof. Dr. · Principal investigator
    • Melitta Köpke, Dr. · Sub investigator
    • Jaqueline Sagasser, Dr. · Sub investigator
    Recruiting
  • Breast Center of the University of Munich (LMU) Universitätsfrauenklinik
    Munich, Bavaria 80336, Germany
    Recruiting
  • Rotkreuz Klinikum München
    Munich, Bavaria 80634, Germany
    • Michael Braun, Prof. Dr. · Contact · michael.braun@swmbrk.de · +49 89 130330
    • Harry Reisch · Contact · harry.reisch@swmbrk.de · +49 89 13033662
    • Michael Braun, Prof. Dr. · Principal investigator
    • Claus Hanusch, Dr. med. · Sub investigator
    Recruiting
  • Klinikum Bremerhaven Reinkenheide
    Bremerhaven, Free Hanseatic City of Bremen 27574, Germany
    Active, not recruiting
  • AGAPLESION Markus Krankenhaus Gynäkologie
    Frankfurt am Main, Hesse 60431, Germany
    • Madeleine Modrow · Contact
    • Marc Thill, Prof. Dr. · Principal investigator
    • Christiane Brandi, Dr. · Sub investigator
    Recruiting
  • Klinikum Frankfurt Höchst GmbH
    Frankfurt am Main, Hesse 65929, Germany
    • Joachim Rom, Prof. Dr. · Contact
    • Joachim Rom, Prof. Dr. · Principal investigator
    • Annette Junker-Stein, Dr. · Sub investigator
    Recruiting
  • Klinikum Kassel
    Kassel, Hesse 34125, Germany
    • Yasmin Baila · Contact
    • Yasmin Baila · Principal investigator
    • Lydia Dautzenberg · Sub investigator
    Recruiting
  • Studien GbR Braunschweig
    Braunschweig, Lower Saxony 38100, Germany
    • Janine Kreiss-Sender, Dr. · Contact
    • Janine Kreiss-Sender, Dr. · Principal investigator
    • Ralf Lorenz, Dr. · Sub investigator
    Recruiting
  • Niels-Stensen-Kliniken Franziskus-Hospital
    Georgsmarienhütte, Lower Saxony 49124, Germany
    Recruiting
  • Ärztehaus am Bahnhofsplatz
    Hildesheim, Lower Saxony 31134, Germany
    • Christoph Uleer, Dr. · Contact
    • Christoph Uleer, Dr. · Principal investigator
    • Jasmin Pourfard, Dr. · Sub investigator
    Recruiting
  • MVZ Klinik Dr. Hancken GmbH
    Stade, Lower Saxony 21680, Germany
    • Birte Rahn · Contact
    • Wiebke Timm, Dr. · Principal investigator
    • Britta Heitmann, Dr. · Sub investigator
    • Stefan Frühhauf, Prof. Dr. · Sub investigator
    Recruiting
  • Universittsklinikum am Klinikum Südstadt
    Rostock, Mecklenburg-Vorpommerns 18059, Germany
    • Michaela Stecher · Contact
    • Kristin Strauß, Dr. · Principal investigator
    • Juliane Terpe-Weiland, Dr. · Sub investigator
    Recruiting
  • Uniklinik RWTH Aachen
    Aachen, North Rhine-Westphalia 52074, Germany
    • Elmar Stickeler, Prof. Dr. · Contact
    • Elmar Stickeler, Prof. Dr. · Principal investigator
    • Brigitte Sophia Winkler, Dr. · Sub investigator
    Recruiting
  • Onkologische Schwerpunktpraxis Bielefeld
    Bielefeld, North Rhine-Westphalia 33604, Germany
    • Siemke Steinke, Dr. · Contact
    • Birgit Reunig-Bruns · Contact
    • Siemke Steinke, Dr. · Principal investigator
    • Hendrik Riesenberg, Dr. med. · Sub investigator
    Recruiting
  • St. Elisabeth Krankenhaus GmbH
    Cologne, North Rhine-Westphalia 50935, Germany
    • Susanne Brandner, Dr. · Contact
    • Susanne Brandner, Dr. · Principal investigator
    • Claudia Schumacher, Dr. · Sub investigator
    Recruiting
  • Kliniken der Stadt Köln GmbH / Brustzentrum Holweide
    Cologne, North Rhine-Westphalia 51067, Germany
    • Fatima Kourisna · Contact
    • Myriam Vincent · Principal investigator
    • Mathias Roland Warm, Prof. Dr. · Sub investigator
    Recruiting
  • Kliniken für Frauenheilkunde / Universitätsklinikum Düsseldorf
    Düsseldorf, North Rhine-Westphalia 40225, Germany
    • Eugen Rückhaberle, Prof. Dr. · Contact
    • Eugen Rückhaberle, Prof. Dr. · Principal investigator
    • Tanja Fehm, Prof. Dr. · Sub investigator
    Recruiting
  • Luisenkrankenhaus GmbH
    Düsseldorf, North Rhine-Westphalia 40235, Germany
    Active, not recruiting
  • Sankt-Antonius-Hospital
    Eschweiler, North Rhine-Westphalia 52249, Germany
    • Gabi Ziemons · Contact
    • Franziska Wilhelm · Contact
    • Peter Staib, Dr. · Principal investigator
    • Matthias Humberg, Dr. med · Sub investigator
    Recruiting
  • Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum
    Essen, North Rhine-Westphalia 45136, Germany
    • Dorothea Schindowski · Contact
    • Sherko Kuemmel, Prof. Dr. · Principal investigator
    • Jennifer Spönlein, Dr. med. · Sub investigator
    Recruiting
  • Universitätsklinikum Essen, Brustzentrum
    Essen, North Rhine-Westphalia 45147, Germany
    • Oliver Hoffmann, Prof. Dr. · Contact · oliver.hoffmann@uk-essen.de
    • Oliver Hoffmann, Prof. Dr. · Principal investigator
    • Ann-Kathrin Bittner, PD Dr. · Sub investigator
    Recruiting
  • Onkodok Gütersloh
    Gütersloh, North Rhine-Westphalia 33332, Germany
    • Reinhard Depenbusch, Dr. · Contact
    • Reinhard Depenbusch, Dr. · Principal investigator
    • Stefan Sonnenberg, Dr. · Sub investigator
    Recruiting
  • St. Barbara Klinik
    Hamm, North Rhine-Westphalia 59073, Germany
    • Claudia Strunk, Dr. · Contact
    • Claudia Strunk, Dr. · Principal investigator
    • Wlodzimierz Badur, Dr. · Sub investigator
    Recruiting
  • Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus
    Mönchengladbach, North Rhine-Westphalia 41061, Germany
    • Raquel von Schumann, Dr. med. · Contact
    • Raquel von Schumann, Dr. med. · Principal investigator
    • Oleg Gluz, PD Dr. med · Sub investigator
    Recruiting
  • MVZ Media Vita am St. Franziskus Hospital
    Münster, North Rhine-Westphalia 48145, Germany
    • Stefanie Wiebe, Dr. · Contact
    • Stefanie Wiebe, Dr. · Principal investigator
    • Corina Neumann, Dr. · Sub investigator
    Recruiting
  • Frauenklinik St. Louise-St. Vincenz-KH GmbH
    Paderborn, North Rhine-Westphalia 33098, Germany
    • Michael Patrick Lux, Prof. Dr. · Contact
    • Michael Patrick Lux, Prof. Dr. · Principal investigator
    • Michaela Wüllner, Dr. · Sub investigator
    Recruiting
  • MKS St. Paulus GmbH
    Schwerte, North Rhine-Westphalia 58239, Germany
    • Johanna Westkämper · Contact
    • Asja Sborowski, Dr. · Principal investigator
    • Michael Hartmann, Dr. · Sub investigator
    Recruiting
  • Praxisnetzwerk Hämatologie und intern. Onkologie
    Troisdorf, North Rhine-Westphalia 53840, Germany
    • Andreas Diel · Contact
    • Andreas Diel · Principal investigator
    • Ernst Rodermann, Dr. · Sub investigator
    Recruiting
  • Marien-Hospital Witten
    Witten, North Rhine-Westphalia 58452, Germany
    • Monika Graeser, Prof. Dr. · Contact
    • Monika Graeser, Prof. Dr. · Principal investigator
    Not yet recruiting
  • Helios-Klinik Wuppertal
    Wuppertal, North Rhine-Westphalia 42283, Germany
    • Vesna Bjelic-Radisic, Prof. Dr. · Contact
    • Vesna Bjelic-Radisic, Prof. Dr. · Principal investigator
    • Oliver Schmalz, Dr. · Sub investigator
    • Bianca Böning, Dr. · Sub investigator
    Recruiting
  • Klinikum Mutterhaus
    Trier, Rhineland-Palatinate 54290, Germany
    • Sebastian Jud, Prof. Dr. · Contact
    • Sebastian Jud, Prof. Dr. · Principal investigator
    • Marion Klieden, Dr. · Sub investigator
    Recruiting
  • CaritasKlinikum Saarbrücken St. Theresia
    Saarbrücken, Saarland 66113, Germany
    • Mustafa Deryal, Dr. · Contact
    • Mustafa Deryal, Dr. · Principal investigator
    • Carolin Beckmann, Dr. · Sub investigator
    Recruiting
  • Universitätsklinikum Leipzig
    Leipzig, Saxony 04103, Germany
    • Bahriye Aktas, Prof. Dr. · Contact
    • Bahriye Aktas, Prof. Dr. · Principal investigator
    • Dirk Forstmeyer, Dr. · Sub investigator
    • Susanne Briest, Dr. · Sub investigator
    Recruiting
  • Frauenklinik / Brustzentrum am Klinikum Obergölzsch Rodewisch
    Rodewisch, Saxony 08228, Germany
    • Barbara Prediger, Dr. · Contact
    • Barbara Prediger, Dr. · Principal investigator
    • Stefanie Strobel, Dr. · Sub investigator
    • Jiri Pomyje, MUDr. · Sub investigator
    Recruiting
  • UK Schleswig Holstein
    Lübeck, Schleswig-Holsteins 23538, Germany
    • Maggie Banys-Paluchowski, Prof. Dr. · Contact
    • Maggie Banys-Paluchowski, Prof. Dr. · Principal investigator
    • Kaschner Katharina · Sub investigator
    Recruiting
  • Charite Campus Mitte
    Berlin, 10117, Germany
    Active, not recruiting
  • Ev. Waldkrankenhaus Spandau
    Berlin, 14589, Germany
    • Silke Polata, Dr. · Contact
    • Silke Polata, Dr. · Principal investigator
    • Sonja Cárdenas-Ovalle, Dr. · Sub investigator
    Recruiting
  • Universitätsklinikum Hamburg-Eppendorf / Klinik und Poliklinik für Gynäkologie
    Hamburg, 20246, Germany
    • Lisa Steinhilper, Dr. · Contact
    • Lisa Steinhilper, Dr. · Principal investigator
    • Kerstin Riecken, Dr. · Sub investigator
    Recruiting
  • Brustzentrum am Krankenhaus Jerusalem
    Hamburg, 20357, Germany
    • Christian Schem, Prof. Dr. · Contact
    • Anne-Sophie Adam, Dr. · Contact
    • Christian Schem, Prof. Dr. · Principal investigator
    • Anne-Sophie Adam, Dr. · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05704829
Lead sponsor
West German Study Group
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Jan 30, 2023
Start date
Feb 5, 2024
Primary completion
Jun 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Jun 9, 2026

Study contacts

Anja Braschoß, MD
Contact
anja.braschoss@wsg-online.com
+4917682119153
Pauline Tholen
Contact
pauline.tholen@wsg-online.com
+492161566230
Nadia Harbeck, Prof. Dr.
principal investigator · Breast Centre, Dept. Obstetrics & Gynaecology and CCC Munich LMU University Hospital
Sherko Kuemmel, PRof. Dr.
principal investigator · Breast Centre, Kliniken Essen Mitte Essen
Oleg Gluz, PD Dr.
principal investigator · Breast Centre, Evang. Bethesda-Hospital Moenchengladbach
Michael Braun, Prof. Dr.
principal investigator · Breast Centre Rotkreuzklinikum Munich
Monika Graeser, PD Dr.
principal investigator · Breast Centre, Evang. Bethesda-Hospital Moenchengladbach

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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