Combination therapy for recurrent triple-negative breast cancer

Randomized Phase II Study of Pembrolizumab + Paclitaxel +/- Bevacizumab in Patients With Recurrent Triple-Negative Breast Cancer Who Received Perioperative Immunotherapy

This study is testing a combination of two drugs, pembrolizumab and paclitaxel, to see if they can help people with recurrent triple-negative breast cancer who haven't had chemotherapy before.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Japanese Foundation for Cancer Research (other)
• Drugs / interventions: chemotherapy, pembrolizumab, atezolizumab, Bevacizumab
• Locations: 15 sites (Nagoya, Aichi-ken and 14 other locations)
• Trial ID: NCT06976944 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed recurrent triple-negative breast cancer who are PD-L1 positive.

Not a fit: Patients who have previously undergone chemotherapy for recurrent breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with recurrent triple-negative breast cancer, potentially improving survival rates.

How similar studies have performed: Previous studies have shown promising results with similar combinations of immune checkpoint inhibitors and chemotherapy in treating triple-negative breast cancer.

Eligibility criteria

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 not undergone chemotherapy for recurrent breast cancer. However, prior treatment of Olaparib for metastatic recurrence or unresectable advanced cancer in participants with BRCA gene pathogenic variant is allowed.
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 this trial is running

Nagoya, Aichi-ken and 14 other locations

• 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)
• Akita University Hospital — Akita, Akita, Japan (NOT_YET_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)
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan (RECRUITING)
• Hyogo Cancer Center — Akashi-shi, Hyōgo, Japan (RECRUITING)
• Okayama University Hospital — Okayama, Okayama-ken, Japan (RECRUITING)
• Osaka International Cancer Institute — Osaka, Osaka, Japan (RECRUITING)
• Osaka Metropolitan University Hospital — Osaka, Osaka, Japan (RECRUITING)
• Kindai University Hospital — Sakai-shi, Osaka, Japan (RECRUITING)
• Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (RECRUITING)
• SHOWA Medical University Hospital — Shinagawa-ku, Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: Yukinori Ozaki

Conditions: Recurrent Triple-Negative Breast Cancer, Recurrent Triple-Negative, Breast Cancer, checkpoint inhibitor, angiogenesis inhibitor