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Status unknownNCT04303988Updated Jul 18, 2024

A Phase II Study of Triple-negative Breast Cancer Brain Metastases.

A Phase 2 interventional study of SHR-1316 and Bevacizumab in Breast Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases.

Read the detailed description

This is a prospective, single-arm, single-center, Simon's two-stage design, phase II clinical trial in triple-negative breast cancer brain metastases patients. Subjects will receive bevacizumab,SHR1316 combined with cisplatin/carboplatin,and will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, or investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 35 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Age ≥ 18 years old, and ≤ 70 years old, both genders;
  2. ECOG performance status 0-2;
  3. Pathological tests confirm HR-negative / HER2-negative breast cancer; there is evidence of local recurrence or metastasis;not suitable with curative surgery or radiation therapy;HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \<1%;HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-);
  4. It is required that no platinum drugs have been used before, or platinum drugs have been used (cisplatin/carboplatin only one regimen) and platinum sensitive: no progression during at least 4 cycles of treatment, more than 3 months period between last platinum regimen and the progression of disease;
  5. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy;
  6. Mannitol or steroid hormone therapy is allowed before enrollment, but the dose of steroid hormone should be stable for at least one week;
  7. Adequate function of major organs meets the following requirements:

(1)Blood routine ANC≥1.5×109/L; PLT≥75×109/L; Hb≥90 g/L(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation: INR≤1.5,APTT≤1.5×ULN, PT does not exceed the upper limit of normal (3)Blood biochemistry TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula) (4)Cardiac ultrasound: LVEF≥50%; (5)12-lead ECG: females QTcF interval \<470msec and males \<450ms; 8.Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.

Exclusion criteria

Exclusion Criteria:

  1. Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture.
  2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
  3. Whole brain radiotherapy, chemotherapy or surgery within 14 days prior to enrollment. Has received prior therapy with Targeted therapy or Endocrine therapy within the previous week;
  4. Subjects with HR-/HER2- who has received prior therapy with bevacizumab or PD-1/PD-L1;
  5. Participation in any other clinical trials within 2 weeks of enrollment;
  6. Concurrent use of any other Anti-cancer drugs;
  7. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma;
  8. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study;
  9. History of allergy or hypersensitivity to any of the study drugs or study drug components;
  10. History of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation;
  11. A clear history of neurological or mental disorders, including epilepsy or dementia;
  12. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation;
  13. According to the investigator's judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs);
  14. Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Cohort HR-/HER2-

    Hormone receptor negative, HER2 negative participants will receive SHR1316 in combination with bevacizumab plus cisplatin or carboplatin until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

    Drug: SHR-1316 · Drug: Bevacizumab · Drug: Cisplatin/Carboplatin

Interventions

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What researchers measure

Primary outcomes

  1. Overall Response Rate in the CNS

    CNS ORR will be assessed by the investigator according to RANO-BM criteria. According to these criteria Complete Response (CR) will be defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions, no corticosteroids; stable or improved clinically. Partial Response (PR) will be defined as a decrease of at least 30% in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD, sustained for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically.

    Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months

Secondary outcomes

  1. Clinical Benefit Rate in the CNS

    CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.

    Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months

  2. Progression-free survival

    PFS will be defined as the time from the first dose of treatment to death or disease progression.

    Time frame: Up to 2 years

  3. Overall survival

    OS will be defined as the time from the first dose of treatment to death for any cause.

    Time frame: Up to 2 years

  4. First progression site

    The first lesion to progress.

    Time frame: Up to 2 years

  5. Safety as assessed by percentage of patients with any Adverse Event

    Adverse event according to NCI-CTC AE 5.0

    Time frame: Up to 2 years

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
08

References and documents

Publications

  • Li T, Zhou T, Wang B, Tao Z, Zhao M, Wang L, Jin J, Zhao Y, Gong C, Cao J, Miao H, Peng W, Wang J, Jin M, Hu X, Zhang J. Phase II Clinical Study of Adebrelimab and Bevacizumab Combined With Cisplatin/Carboplatin in Patients With Triple-Negative Breast Cancer With Brain Metastases (ABC Study). J Clin Oncol. 2026 Sep 10;44(26):2543-2553. doi: 10.1200/JCO-25-02021. Epub 2026 Mar 4. PubMed 41779972 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04303988
Lead sponsor
Fudan University
Responsible party
Jian Zhang,MD (Chief Physician, Fudan University) — Principal investigator
First posted
Mar 11, 2020
Start date
Mar 30, 2020
Primary completion
Dec 30, 2024 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Jul 18, 2024

Study contacts

Jian Zhang, MD
Contact
syner2000@163.com
13918273761
Ting Li, MD
Contact
13917792964
Jian Zhang, MD
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Adebrelimab · Bevacizumab · Cisplatin · Carboplatin

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