Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06976944

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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

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