Combination therapy for recurrent triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of pembrolizumab combined with paclitaxel, with or without bevacizumab, in treating recurrent triple-negative breast cancer. The study focuses on patients who are PD-L1 positive and have not previously undergone chemotherapy for their recurrent condition. The approach aims to leverage the immune checkpoint inhibitor pembrolizumab alongside traditional chemotherapy to improve patient outcomes. The trial is conducted in a phase 2 setting, indicating a focus on assessing the treatment's effectiveness and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male/female participants who are 18 years of age or older on the day of signing informed consent with histologically or cytologically confirmed diagnosis of invasive breast cancer will be enrolled in this study.
2. Participants have been confirmed to be ER negative, HER2 negative according to the latest ASCO/CAP criteria. However, it does not matter whether the result is positive or negative for PgR.
3. Participants have been confirmed to be PD-L1 positive in each site's evaluation using biopsy specimen or surgical specimen.
4. Participants who have received not more than 1 prior chemotherapy regimen (including those with no prior chemotherapy) for recurrent breast cancer, excluding trial drugs of this clinical trial. (Participants with prior paclitaxel or bevacizumab for recurrent breast cancer are excluded.) However, prior treatment with Olaparib for metastatic recurrence or unresectable advanced cancer in participants with BRCA gene pathogenic variant is allowed (not counted as 1 regimen).
5. Participants must have recurred after treatment with an anti-PD-1/PD-L1 antibody administered as monotherapy or in combination with other ICIs or chemotherapies as a perioperative drug therapy for triple negative breast cancer.
6. Have an Eastern Cooperative Oncology Group performance status of 0 to 1.

Exclusion Criteria:

1. Participants with progressive disease on RECIST or clinically diagnosed during preoperative ICI and chemotherapy.
2. Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment.
3. Has known active CNS metastases and/or carcinomatous meningitis.
4. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Where it's running

• National Hospital Organization Nagoya Medical Center
  Nagoya, Aichi-ken, Japan Recruiting
• Nagoya University Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Nagoya City University Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• National Cancer Center Hospital East
  Kashiwa-shi, Chiba, Japan Recruiting
• Gifu University Hospital
  Gifu, Gifu, Japan Recruiting
• Hiroshima University Hospital
  Hiroshima, Hiroshima, Japan Recruiting

Study contacts

• Study coordinator: Yukinori Ozaki
• Email: yukinori.ozaki@jfcr.or.jp
• Phone: +81-3-3520-0111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.