Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
* 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek minimum 18 lat
- •Potwierdzony nowotwór piersi o charakterze potrójnie negatywnym (brak receptorów estrogenowych i HER2)
- •Wykazanie dodatniego markera PD-L1 w biopsji
- •Nawrót raka po wcześniejszym leczeniu immunoterapią (anti-PD-1/PD-L1) w okresie operacyjnym
- •Maksymalnie jeden schemat chemioterapii wcześniej na nawrót (wyłączając paclitaxel i bevacizumab)
- •Dobry stan ogólny (zdolność do codziennych aktywności)
✗ Disqualifies
- •Pogorszenie się choroby podczas poprzedniego leczenia immunoterapią i chemioterapią
- •Inny nowotwór wymuszający leczenie w ciągu ostatnich 3 lat
- •Przerzuty do mózgu lub opon mózgowych
- •Historia zapalenia płuc/chorób śródmiąższowych wymagających sterydów lub obecne zapalenie płuc
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (14)
National Hospital Organization Nagoya Medical Center
Nagoya, Japan
Nagoya University Hospital
Nagoya, Japan
Nagoya City University Hospital
Nagoya, Japan
National Cancer Center Hospital East
Kashiwa-shi, Japan
Gifu University Hospital
Gifu, Japan
Hiroshima University Hospital
Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Japan
Hyogo Cancer Center
Akashi-shi, Japan
Okayama University Hospital
Okayama, Japan
Osaka International Cancer Institute
Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Kindai University Hospital
Sakai-shi, Japan
Cancer Institute Hospital of JFCR
Koto-ku, Japan
SHOWA Medical University Hospital
Shinagawa-ku, Japan
Trial contact
Yukinori Ozaki
Kazuki Nozawa
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/14/2026.
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