NCT05020860 · Baylor Breast Care Center
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
(RESPONSE)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Paclitaxel
80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle
DRUG
Carboplatin
Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle
DRUG
Trastuzumab
Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle
DRUG
Pertuzumab
Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle
DRUG
Doxorubicin
60 mg/m2 IV administered on Day 1 of each 14-day cycle
DRUG
Cyclophosphamide
600 mg/m2 IV administered on Day 1 of each 14-day cycle
DRUG
Pembrolizumab
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.
DRUG
Pertuzumab/Trastuzumab/Hyaluronidase-zzxf
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.
Primary outcome measures
Change in Clinical Tumor Measurement vs. Pathologic Response
Time frame: Baseline and at surgery (after 20 weeks)
Clinical tumor measurements are tumor measurements obtain via imaging (mammogram or ultrasound) or by physical exam. Pathologic response is the amount of tumor remaining at the time of surgery, as determined by the pathologist.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.
- Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines). To be considered "high risk," at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \< 6; 4) Ki-67 ≥ 30%.
- Tumors must be at least 2 cm by clinical exam or ultrasound
- Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVE
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2025 · Source of record for eligibility and locations