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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• Participants have been confirmed to be PD-L1 positive in each site's evaluation using biopsy specimen or surgical specimen.

• 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.

• 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.

• Have an Eastern Cooperative Oncology Group performance status of 0 to 1.

Locations
Other Locations
Japan
Hyogo Cancer Center
RECRUITING
Akashi-shi
Akita University Hospital
NOT_YET_RECRUITING
Akita
Gifu University Hospital
RECRUITING
Gifu
Hiroshima University Hospital
NOT_YET_RECRUITING
Hiroshima
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa-shi
Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
Nagoya City University Hospital
NOT_YET_RECRUITING
Nagoya
Nagoya University Hospital
RECRUITING
Nagoya
National Hospital Organization Nagoya Medical Center
RECRUITING
Nagoya
Okayama University Hospital
RECRUITING
Okayama
Osaka International Cancer Institute
RECRUITING
Osaka
Osaka Metropolitan University Hospital
NOT_YET_RECRUITING
Osaka
Hokkaido University Hospital
RECRUITING
Sapporo
Kindai University Hospital
NOT_YET_RECRUITING
Sayama-shi
SHOWA Medical University Hospital
RECRUITING
Shinagawa-ku
Contact Information
Primary
Yukinori Ozaki
yukinori.ozaki@jfcr.or.jp
+81-3-3520-0111
Backup
Kazuki Nozawa
k.nozawa@med.nagoya-cu.ac.jp
+81-52-851-5511
Time Frame
Start Date: 2025-07
Estimated Completion Date: 2028-09
Participants
Target number of participants: 44
Treatments
Experimental: Pembrolizumab + paclitaxel + bevacizumab
Active_comparator: Pembrolizumab + paclitaxel
Related Therapeutic Areas
Sponsors
Leads: Yukinori Ozaki
Collaborators: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov