BridgeMD
A translational RANDOMIZED phase III study exploring the effect of the addition of capecitabine to Carboplatinum based chemotherapy in early “triple negative” breast cancer
EU CTIS ID: 2022-501102-35-00
What this study is testing
To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent approved by the Ethical Review Board (IRB).
- Willingness of female patients of childbearing potential, male patients and their sexual partners to use an effective means of contraception during the treatment period and at least 6 months thereafter.
- Willingness by the patient to undergo treatment and study related procedures according to the protocol.
- Age ≥ 18 to < 76 years.
- Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvant chemotherapy followed by definitive surgery is planned.
- Node positive disease (N1-3) or if clinically N0 Tumor over 20 mm.
You likely can't join if
- Clinical or radiological signs of metastatic disease.
- History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer.
- Previous chemotherapy for cancer or other malignant disease.
- Charlson comorbidity index, excluding score for malignancy: (CCI) > 2, Comment: In patients 70-75 a CCI = 3 is allowed, see appendix B.
- Inadequate organ function, suggested by the following laboratory results: a Absolute neutrophil count < 1,5 x 109/L b Platelet count < 100 x 109/L c Haemoglobin < 90 g/L d Total bilirubin greater than the upper limit of normal (ULN) unless the patient has documented Gilbert´s syndrome e ASAT (SGOT) and/or ALAT (SGPT) > 2,5 x ULN f ASAT (SGOT) and/or ALAT (SGPT) > 1,5 x ULN with concurrent serum alkaline phosphatase (ALP) > 2,5 x ULN g Serum creatinine clearance < 50 ml/min
- Concurrent peripheral neuropathy of grade 3 or greater (NCI-CTCAE, Version 5.0)
See the full eligibility criteria
- Signed written informed consent approved by the Ethical Review Board (IRB).
- Willingness of female patients of childbearing potential, male patients and their sexual partners to use an effective means of contraception during the treatment period and at least 6 months thereafter.
- Willingness by the patient to undergo treatment and study related procedures according to the protocol.
- Age ≥ 18 to < 76 years.
- Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvant chemotherapy followed by definitive surgery is planned.
- Node positive disease (N1-3) or if clinically N0 Tumor over 20 mm.
- ER negative tumor defined by at least one the following: a. ER < 1% cells positive by immunohistochemistry (IH.C) or ER < 10% cells positive by IHC and basal-like subtype using gene expression analysis b. ER < 10% cells positive by IHC and < 10% cells positive by IHC.
- HER2-normal tumor defined according to applicable national guidelines.
- Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breast cancer associated genes.
- WHO performance status 0 or 1.
- Negative pregnancy test in women of childbearing potential (premenopausal or <12 months of amenorrhea post-menopause and who have not undergone surgical sterilization).
- Clinical or radiological signs of metastatic disease.
- History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer.
- Previous chemotherapy for cancer or other malignant disease.
- Charlson comorbidity index, excluding score for malignancy: (CCI) > 2, Comment: In patients 70-75 a CCI = 3 is allowed, see appendix B.
- Inadequate organ function, suggested by the following laboratory results: a Absolute neutrophil count < 1,5 x 109/L b Platelet count < 100 x 109/L c Haemoglobin < 90 g/L d Total bilirubin greater than the upper limit of normal (ULN) unless the patient has documented Gilbert´s syndrome e ASAT (SGOT) and/or ALAT (SGPT) > 2,5 x ULN f ASAT (SGOT) and/or ALAT (SGPT) > 1,5 x ULN with concurrent serum alkaline phosphatase (ALP) > 2,5 x ULN g Serum creatinine clearance < 50 ml/min
- Concurrent peripheral neuropathy of grade 3 or greater (NCI-CTCAE, Version 5.0)
- Patient who is actively breast feeding.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Patients with known deficiency of the DPD-enzyme who completely lack DPD.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.