RecruitingPhase 2NCT06976944

Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer

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


Sponsor

Yukinori Ozaki

Enrollment

44 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

* Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classified into four subtypes according to the expression levels of hormone receptor (HR) and human epidermal growth factor receptor type 2 (HER2). Among them, triple negative breast cancer accounts for 10% of invasive cancers and is the subtype with the poorest prognosis. * For triple negative breast cancer that is operable, chemotherapy with pembrolizumab is administered either preoperatively or postoperatively (perioperative period). For recurrent triple negative breast cancer , combination chemotherapy with multiple agents is the standard of care, especially in the case of PD-L1-positive patients, chemotherapy with an immune checkpoint inhibitor related to PD-1 (pembrolizumab or atezolizumab) is administered. * Although the KEYNOTE355 trial demonstrated the efficacy of pembrolizumab plus paclitaxel therapy in patients with PD-L1-positive triple negative breast cancer in postoperative relapse, this trial did not include patients who received pembrolizumab in the perioperative period. Therefore, it is not known if there is any benefit to re-administering pembrolizumab to these patients after relapse. * Bevacizumab is used as standard therapy for triple negative breast cancer in combination with paclitaxel. Bevacizumab itself is an anti-tumor agent that inhibits angiogenesis, but has also been reported to activate immunity against cancer, suggesting that it may enhance the effect of pembrolizumab. Based on the above, the investigators planned this trial to evaluate whether pembrolizumab + paclitaxel + bevacizumab therapy is more effective than pembrolizumab + paclitaxel therapy in PD-L1-positive triple negative breast cancer patients who relapse after receiving immune checkpoint inhibitors in the perioperative period.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding bevacizumab (a drug that blocks blood vessel growth in tumors) to a combination of pembrolizumab (an immunotherapy) and paclitaxel (chemotherapy) helps people with triple-negative breast cancer that has come back after earlier immunotherapy treatment. **You may be eligible if...** - You are 18 or older - You have triple-negative breast cancer (ER-negative and HER2-negative) - Your cancer tests positive for PD-L1 (a marker that suggests immunotherapy may help) - Your cancer has returned after you previously received a checkpoint immunotherapy drug (like pembrolizumab) as part of your earlier treatment - You have not yet received chemotherapy for your recurrent cancer - You are in good overall health (ECOG 0 to 1) **You may NOT be eligible if...** - Your cancer was already progressing during your earlier immunotherapy treatment - You have another active cancer requiring treatment - You have active brain metastases - You have a history of serious lung inflammation that required steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Pembrolizumab: Intravenous infusion(400 mg/body, every 6 weeks starting on Day 1 of Cycle 1)

DRUGPaclitaxel

Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Paclitaxel: Intravenous infusion(90 mg/m\^2, on Days 1, 8, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle)

DRUGBevacizumab

Protocol treatment will continue until worsening of the participant's underlying disease or unacceptable toxicity is observed or the participant withdraws the consent, or the participant meets other discontinuation criteria. Bevacizumabl: Intravenous infusion(10 mg/kg, on Days 1, and 15, starting on Day 1 of Cycle 1 with a 28-day cycle)


Locations(15)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Akita University Hospital

Akita, Akita, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Gifu University Hospital

Gifu, Gifu, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Cancer Center

Akashi-shi, Hyōgo, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Kindai University Hospital

Sakai-shi, Osaka, Japan

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

SHOWA Medical University Hospital

Shinagawa-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06976944