Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
RESPONSE
A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer
1 other identifier
interventional
185
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Apr 2023
Typical duration for phase_2 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedStudy Start
First participant enrolled
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
February 27, 2025
January 1, 2025
4.3 years
August 19, 2021
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Clinical Tumor Measurement vs. Pathologic Response
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.
Baseline and at surgery (after 20 weeks)
Secondary Outcomes (2)
Pathologic Complete Response Rate in each Breast Cancer Subtype
20 weeks
Predictive value of clinical response following 1 cycle of chemotherapy to predict pathologic complete response
20 weeks
Other Outcomes (1)
Change in circulating tumor DNA (ctDNA) levels from baseline to surgery
20 weeks
Study Arms (4)
Triple Negative Breast Cancer (for tumors > 5 cm)
ACTIVE COMPARATORPaclitaxel IV plus carboplatin IV (+/- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+/- pembrolizumab IV) (4 cycles total)
Triple Negative Breast Cancer (for tumors < 5 cm)
ACTIVE COMPARATORPaclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)
HER2-Positive Breast Cancer
ACTIVE COMPARATORPaclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total)
Hormone Receptor Positive Breast Cancer
ACTIVE COMPARATORPaclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total)
Interventions
80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle
Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle
Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle
Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle
60 mg/m2 IV administered on Day 1 of each 14-day cycle
600 mg/m2 IV administered on Day 1 of each 14-day cycle
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.
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.
Eligibility Criteria
You may qualify if:
- 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 (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.
- Adequate organ function, as determined by the following parameters:
- Absolute Neutrophil Count (ANC) ≥ 1200/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome
- Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
- Serum creatinine ≤ institutional ULN
- +2 more criteria
You may not qualify if:
- Definitive clinical or radiologic evidence of Stage IV disease
- Inflammatory breast cancer
- Participants who are pregnant or lactating
- History of an excisional biopsy or lumpectomy performed prior to study entry
- Prior treatment with anthracyclines for any malignancy.
- Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
- History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:
- Angina pectoris requiring the use of anti-anginal medication
- Ventricular arrhythmias except for benign premature ventricular contractions
- Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
- Conduction abnormality requiring a pacemaker
- Valvular disease with documented compromise in cardiac function
- Symptomatic pericarditis
- Documented cardiomyopathy
- History of documented congestive heart failure (CHF)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Harris Health System - Smith Clinic
Houston, Texas, 77054, United States
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77054, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mothaffar Rimawi, MD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 19, 2021
First Posted
August 25, 2021
Study Start
April 18, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
November 1, 2029
Last Updated
February 27, 2025
Record last verified: 2025-01