Blood and imagE-guided Optimization of Neoadjuvant Therapy in People With Early Stage Triple-negative Breast cancER - the BETTER Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07610525
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel + Carboplatin — DRUG
    Given by IV
  • Pembrolizumab — DRUG
    Given by IV

Study Details

To learn whether certain blood and imaging tests can show which people with early-stage TNBC may already have had a complete response to chemotherapy before they go to surgery.

Key Dates

Start date
Nov 5, 2026
Status verified
May 2026
Primary completion
Jan 15, 2029
Completion
Jan 15, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1
    Cohort A1 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles
  • Experimental: Cohort A2
    Cohort A2 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
  • Experimental: Cohort B1
    Cohort B1 Receiving AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles + (AC/PB) x 4 cycles
  • Experimental: Cohort B2
    Cohort B2 Omiting AC/PB: Paclitaxel+Carboplatin+Pembrolizumab x 4 cycles

Primary Outcome Measure

Safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Akshara S Raghavendra, MD
[email protected]
713-792-2817
Clinton Yam, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
MD Anderson Cancer Center· Houston, TX

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