The goal of this clinical trial is to compare the effectiveness of several treatment regimens for stage I triple negative breast cancer before surgery. The main question it aims to answer is if these regimens will reduce or completely remove all cancer cells before surgery.
Must have histologically confirmed invasive triple negative breast cancer as defined by ER/PR <10% and HER2 negative by ASCO/CAP criteria or disease consistent with TNBC by physician assessment, with confirmation by study PI.
Must have untreated, non-metastatic (M0), cT1 (T1a-T1c) N0 disease. Biopsies of suspicious lymph nodes to confirm nodal status are required.
Bilateral or multifocal disease can be included as long as all areas have been biopsied and are consistent with invasive triple negative breast cancer. In the case of bilateral or multifocal disease, the tumor with the most advanced T stage should be used to assess eligibility.
The patient must be ≥ 18 years of age on day of signing informed consent.
A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see Appendix A). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Has received systemic anti-cancer therapy, including investigational agents, prior to randomization.
If the participant has received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Parallel
Pembrolizumab
DrugPembrolizumab 200 mg fixed dose IV once every 3 weeks
Paclitaxel (Chemotherapy)
DrugPaclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle
Carboplatin
DrugCarboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle
Rate of Pathologic complete response (pCR)
To describe rates of pCR in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel-pembrolizumab. pCR is defined as the absence of residual invasive cancer in the breast and all sampled regional lymph nodes following neoadjuvant therapy. It is assessed by histopathologic examination.
Residual disease burden
To describe residual disease burden at time of surgery in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel-pembrolizumab. Residual disease will be assessed by histopathologic examination. It is measured by the residual cancer burden index (Residual Cancer Burden Calculator): https://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Rate of treatment discontinuation
To assess the rate of treatment discontinuation due to poor response for each treatment arm prior to cycle 3. To describe the rate of treatment discontinuation in each arm, which is defined as the proportion of patients that are removed from study at interval imaging due to Poor Response compared to the total number of patients treated on the arm.
Assess 3-year invasive disease-free survival (IDFS)
To assess 3-year invasive disease-free survival (IDFS) in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel-pembrolizumab. IDFS will be defined by the Neo-STEEP (Standardized Definitions for Efficacy End Points) system for adjuvant breast cancer trials.
Treatment-related adverse events
To describe treatment-related adverse events in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin- paclitaxel-pembrolizumab. These will be defined and graded by the NCI's CTCAE (Common Terminology Criteria for Adverse Events) version 6.0.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
