Actively Recruiting
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
Led by Yukinori Ozaki · Updated on 2026-02-23
44
Participants Needed
15
Research Sites
166 weeks
Total Duration
On this page
Sponsors
Y
Yukinori Ozaki
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
* 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.
CONDITIONS
Official Title
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with histologically or cytologically confirmed invasive breast cancer
- Confirmed estrogen receptor (ER) negative and HER2 negative status per latest ASCO/CAP criteria; progesterone receptor (PgR) status does not affect eligibility
- Confirmed PD-L1 positive status based on biopsy or surgical specimen
- No prior chemotherapy for recurrent breast cancer, except prior Olaparib allowed for BRCA gene variant metastatic or unresectable cancer
- Recurrence after treatment with anti-PD-1/PD-L1 antibody given as monotherapy or combined with other immune checkpoint inhibitors or chemotherapies in perioperative setting for triple-negative breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You will not qualify if you...
- Progressive disease during preoperative immune checkpoint inhibitor and chemotherapy treatment
- Active additional malignancy requiring treatment or progressing within the past 3 years
- Known active central nervous system metastases or carcinomatous meningitis
- History or current presence of non-infectious pneumonitis or interstitial lung disease requiring steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 460-0001
Actively Recruiting
2
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
3
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
4
Akita University Hospital
Akita, Akita, Japan, 010-8543
Not Yet Recruiting
5
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
6
Gifu University Hospital
Gifu, Gifu, Japan, 501-1194
Actively Recruiting
7
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
8
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
9
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan, 673-8558
Actively Recruiting
10
Okayama University Hospital
Okayama, Okayama-ken, Japan, 700-8558
Actively Recruiting
11
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
12
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan, 545-0051
Actively Recruiting
13
Kindai University Hospital
Sakai-shi, Osaka, Japan, 590-0197
Actively Recruiting
14
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
15
SHOWA Medical University Hospital
Shinagawa-ku, Tokyo, Japan, 142-8666
Actively Recruiting
Research Team
Y
Yukinori Ozaki
CONTACT
K
Kazuki Nozawa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here