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New treatment option for Recurrent Triple-Negative Breast Cancer
Official title Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT06976944
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent triple-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male/female participants who are 18 years of age or older on the day of signing informed consent with histologically or cytologically confirmed...
- Participants have been confirmed to be ER negative, HER2 negative according to the latest ASCO/CAP criteria. However, it does not matter whether the...
- Participants have been confirmed to be PD-L1 positive in each site's evaluation using biopsy specimen or surgical specimen.
- Participants who have received not more than 1 prior chemotherapy regimen (including those with no prior chemotherapy) for recurrent breast cancer...
- Participants must have recurred after treatment with an anti-PD-1/PD-L1 antibody administered as monotherapy or in combination with other ICIs or...
You likely can't join if
- Participants with progressive disease on RECIST or clinically diagnosed during preoperative ICI and chemotherapy.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
See the full eligibility criteria
- 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 received not more than 1 prior chemotherapy regimen (including those with no prior chemotherapy) for recurrent breast cancer, excluding trial drugs of this clinical trial. (Participants with prior...
- 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...
- Have an Eastern Cooperative Oncology Group performance status of 0 to 1.
- Participants with progressive disease on RECIST or clinically diagnosed during preoperative ICI and chemotherapy.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
The study team makes the final eligibility decision.
Where it's taking place
- Nagoya, Aichi-ken, Japan
- Kashiwa-shi, Chiba, Japan
- Gifu, Gifu, Japan
- Hiroshima, Hiroshima, Japan
- Sapporo, Hokkaido, Japan
- Akashi-shi, Hyōgo, Japan
- Okayama, Okayama-ken, Japan
- Osaka, Osaka, Japan
- Sakai-shi, Osaka, Japan
- Koto-ku, Tokyo, Japan
- Shinagawa-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nagoya, Aichi-ken, Japan; Kashiwa-shi, Chiba, Japan; Gifu, Gifu, Japan; Hiroshima, Hiroshima, Japan; Sapporo, Hokkaido, Japan; Akashi-shi, Hyōgo, Japan and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.