Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer
Baylor Breast Care Center
185 participants
Apr 18, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria17
- 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
- The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.
- Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.
Exclusion Criteria20
- 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)
- Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.
- Current HIV, hepatitis B, or hepatitis C infection
- History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
- Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.
- Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05020860