Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
NCT ID: NCT06976944
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
44 participants
INTERVENTIONAL
2025-07-31
2028-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + paclitaxel + bevacizumab
Pembrolizumab
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)
Paclitaxel
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)
Bevacizumab
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)
Pembrolizumab + paclitaxel
Pembrolizumab
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)
Paclitaxel
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)
Interventions
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Pembrolizumab
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)
Paclitaxel
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)
Bevacizumab
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)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Yukinori Ozaki
OTHER
Responsible Party
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Yukinori Ozaki
Director of Breast Medical Oncology
Principal Investigators
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Toshimi Takano
Role: STUDY_CHAIR
Cancer Institute Hospital of JFCR
Locations
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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
Sayama-shi, Osaka, Japan
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
SHOWA Medical University Hospital
Shinagawa-ku, Tokyo, Japan
Countries
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Central Contacts
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Facility Contacts
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Chiyoe Kitagawa
Role: primary
Madoka Iwase
Role: primary
Kazuki Nozawa
Role: primary
Kaori Terata
Role: primary
Chikako Funasaka
Role: primary
Manabu Futamura
Role: primary
Hideo Shigematsu
Role: primary
Masato Takahashi
Role: primary
Koji Matsumoto
Role: primary
Yuko Takahashi
Role: primary
Takahiro Nakayama
Role: primary
Shinichiro Kashiwagi
Role: primary
Tsutomu Iwasa
Role: primary
Toshimi Takano
Role: primary
Hitomi Sakai
Role: primary
Other Identifiers
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jRCT2031250076
Identifier Type: REGISTRY
Identifier Source: secondary_id
WJOG16522B
Identifier Type: -
Identifier Source: org_study_id
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