A Phase 2 interventional study of Perjeta Injectable Product and Herceptin in Breast Neoplasms, sponsored by Palleos Healthcare GmbH. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Palleos Healthcare GmbH · Phase 2, Interventional, and Treatment
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks with a quality of life assessment for 40 additional weeks in patients with operable HER2+/HR+ breast cancer.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 257 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Palleos Healthcare GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must qualify for neoadjuvant treatment as follows:
Patients of childbearing potential must accept to implement a highly effective (less than 1% failure rate according to Pearl index) non-hormonal contraceptive measures during the study treatment and for 6 months following the last dose of study treatment (trastuzumab and pertuzumab) such as:
Exclusion Criteria:
Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including but not confined to:
Inadequate organ function including but not confined to:
Abnormal blood values:
Neoadjuvant therapy: Trastuzumab and Pertuzumab in a 3-weekly schedule in combination with standard Taxane chemotherapy. Adjuvant Therapy: Standard of care
Drug: Perjeta Injectable Product · Drug: Herceptin · Drug: Tamoxifen · Drug: Paclitaxel · Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Anastrozole · Drug: Letrozole · Drug: Exemestane · Drug: Leuprorelin acetate · Drug: Goserelin · Diagnostic Test: Biopsy · Procedure: Surgery
Neoadjuvant therapy: Trastuzumab and Pertuzumab in a 3-weekly schedule in combination with endocrine therapy. Adjuvant Therapy: Standard of care
Drug: Perjeta Injectable Product · Drug: Herceptin · Drug: Epirubicin · Drug: Cyclophosphamide · Drug: Anastrozole · Drug: Letrozole · Drug: Exemestane · Drug: Paclitaxel · Drug: Tamoxifen · Drug: Leuporelin acetate · Drug: Goserelin · Diagnostic Test: Biopsy · Procedure: Surgery
Single dose of 840mg (loading dose) day1 cycle 1, 420mg at day1 of each subsequent cycle, every 3 weeks. (The latter cycle is called cycle of treatment and is to be given 4 times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Also known as: Pertuzumab
Single dose of 8mg/kg (loading dose) day1 cycle 1; 6mg/kg at day1 of each subsequent cycle body weight every 3 weeks. (This is called cycle of treatment and is to be given four times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Also known as: Trastuzumab
20 mg per day for a total of 40 weeks in the adjuvant therapy phase.
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment and is to be given for 12 weeks in neoadjuvant therapy phase.
12 weeks (4cycles) of max. 90mg/sqm in adjuvant therapy phase
12 weeks (4cycles) of 600 mg/sqm i.v. on day 1+8 or 12 weeks (4cycles) of 500 mg/sqm i.v. on day 1 in adjuvant therapy phase
1mg per day for a total of 40 weeks in adjuvant therapy phase
2,5 mg/day for a total of 40 weeks in adjuvant therapy phase
25mg/day for a total of 40 weeks in adjuvant therapy phase
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
3,6mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
1mg per day for 12 weeks in neoadjuvant therapy phase; 1mg per day for a total of 40 weeks max. in adjuvant therapy phase
2,5 mg per day for 12 weeks in neoadjuvant therapy phase; 2,5 mg perday for a total of 40 weeks max. in adjuvant therapy phase
25mg/day for 12 weeks in neoadjuvant therapy phase; 25mg/day for a total of 40 weeks max. in adjuvant therapy phase
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment an is to be given for 12 weeks in the adjuvant phase
20mg per day (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase.
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
3,5mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)
Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)
Pathological complete response (pCR)
14 weeks after start of therapy treatment, tumor and lymph node biopsy is performed to reach the primary endpoint of pathological complete response (pCR) which is defined as the absence of residual invasive cancer of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ypT0/is ypN0 in the current AJCC staging system). As secondary endpoint, also other response states will be taken into account: no invasive tumor in the complete resected breast specimen irrespective of the lymph node state following completion of neoadjuvant systemic therapy (ypT0/is, any ypN).
Time frame: 14 weeks after start of therapy treatment
Health-related quality of life using EORTC QBL-BR-23 scale
Assessment of quality of life questions during the past week or during the past 4 weeks (depending on the questions) are measured on a 4 level-scale: 1 (not at all); 2 (a little); 3 (quite a bit); 4 (very much)
Time frame: During the neoadjuvant treatment phase at baseline (week 1) and at week 13. In the adjuvant therapy phase, every 3 month, up to 12 months (from date of randomization) or date of drop out, whatever comes first
Health-related quality of life using EQ5D-5L scale
* questions about "self care", "usual activities", "pain /discomfort", anxiety/depression" are assessed on a 5 level-scale using tick boxes : "I have no problem"; "I have slight problems"; "I have moderate problems"; "I have severe problems" "I am unable" * assessment of the patient health (good or bad) is measured on a scale numbered from 0 to 100 (100 means the best heath and 0 means the worst)
Time frame: During the neoadjuvant treatment phase at baseline (week 1) and at week 13. In the adjuvant therapy phase, every 3 month, up to 12 months (from date of randomization) or date of drop out, whatever comes first
Health-related quality of life using EORTC QLQ-C30 scale
* Assessment of quality of life questions (activities, breath, pain, sleep, appetite, vomiting, constipation, others..) are measured on a 4 level-scale: 1 (not at all); 2 (a little); 3 (quite a bit); 4 (very much) * Assessment of Overall health and overall quality of life during the past week is measured on a 7 level-scale going from 1 (very poor) to 7 (excellent)
Time frame: During the neoadjuvant treatment phase at baseline (week 1) and at week 13. In the adjuvant therapy phase, every 3 month, up to 12 months (from date of randomization) or date of drop out, whatever comes first
Tumor size reduction by mammography
The diameters of the tumors in the breast will be measured in millimeter by mammography as part of clinical response measure. The tumor size measurement 13 weeks after start of therapy is also used to reach a secondary endpoint: near pCR, defined as tumor sized ypT1a/is, any ypN with tumor size.
Time frame: at screening visit and 12 weeks after start of therapy treatment
Tumor size reduction by palpation and ultrasound
The diameters of the tumors in the breast will be measured in millimeter by palpation and ultrasound as part of clinical response measure. The tumor size measurement 13 weeks after start of therapy is also used to reach a secondary endpoint: near pCR, defined as tumor sized ypT1a/is, any ypN with tumor size.
Time frame: at screening visit and 4, 7 and 13 weeks after start of therapy treatment
Overall survival
The overall survival is defined as time (days) between study treatment allocation and death of patient due to any cause.
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Duration of invasive disease-free survival
Duration of invasive disease-free survival is defined as time (days) between study treatment allocation and relapse, secondary tumor event or death.
Time frame: From date of treatment allocation until the date of first documented progression or secondary tumor or date of death from any cause, whichever came first, assessed up to 60 months (study duration including follow up)
Number of mastectomies
The number of mastectomies will be determined at time of surgery (week 14 and week 18)
Time frame: 14 weeks after start of therapy treatment
Ki67 level
The level of Ki67 in biopsie material will be measured at week 4 of neoadjuvant therapy
Time frame: 4 weeks after start of therapy treatment
cDNA composition
The composition of cDNA in blood samples will be measured
Time frame: at baseline, 3 weeks, 4 weeks and 6, 18, 24, 36 48 and 60 months after start of therapy treatment
Plan to share: No
Ran from Oct 2017 to primary completion in Jul 2020, 33 months.
Of 218 industry-sponsored phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 55. This study's 33 months is close to that.
Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Palleos Healthcare GmbH