Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor Breast Care Center
Study ID
NCT05020860
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle
  • Carboplatin — DRUG
    Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle
  • Trastuzumab — DRUG
    Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle
  • Pertuzumab — DRUG
    Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle
  • Doxorubicin — DRUG
    60 mg/m2 IV administered on Day 1 of each 14-day cycle
  • Cyclophosphamide — DRUG
    600 mg/m2 IV administered on Day 1 of each 14-day cycle
  • Pembrolizumab — DRUG
    Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen. 400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen.
  • Pertuzumab/Trastuzumab/Hyaluronidase-zzxf — DRUG
    Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks.

Study Details

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Key Dates

Start date
Apr 18, 2023
Status verified
Jan 2025
Primary completion
Aug 31, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
185 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Triple Negative Breast Cancer (for tumors > 5 cm)
    Paclitaxel IV plus carboplatin IV (+/- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+/- pembrolizumab IV) (4 cycles total)
  • Active Comparator: Triple Negative Breast Cancer (for tumors < 5 cm)
    Paclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)
  • Active Comparator: HER2-Positive Breast Cancer
    Paclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total)
  • Active Comparator: Hormone Receptor Positive Breast Cancer
    Paclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)

Primary Outcome Measure

Change in Clinical Tumor Measurement vs. Pathologic Response [ Time Frame: Baseline and at surgery (after 20 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Harris Health System - Smith ClinicHoustonTexas77054
Maria Rodriguez
[email protected]
713-798-8347
Mothaffar Rimawi, MD (PRINCIPAL_INVESTIGATOR)
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer CenterHoustonTexas77054
Maria Rodriguez
[email protected]
713-798-8347
Mothaffar Rimawi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Harris Health System - Smith Clinic· Houston, TXO'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center· Houston, TX

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