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

• Status: Not yet recruiting
• Trial end date: 2028-01-01
• Target enrollment: 0
• Participant gender: All

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 patients with breast cancer who are receiving chemotherapy prior to surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Breast Care Center
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Paclitaxel; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• Must be at least 18 years old, and legally able to provide informed consent. Both men and women are eligible.

• Participants must have 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). High risk is defined as a tumor that meets at least two of the following criteria: 1) histologic grade 3; 2) patient age less than 50 years; 3) Estrogen Receptor (ER) < 6/ or 4) ki-67 ≥ 30%.

• Tumors must be at least 2 cm by clinical exam (palpation or ultrasound).

• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Participants must have a left ventricular ejection fraction ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.

• Participants must have adequate organ function, as determined by the following parameters:

• Absolute Neutrophil Count (ANC) ≥ 1200/mm3

• Platelets ≥ 100,000/mm3

• Hemoglobin ≥ 10 g/dL

• Total bilirubin ≤ institutional upper limit of normal (ULN), unless the 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 patient, 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 Criteria:

• Participants must not have definitive clinical or radiologic evidence of Stage IV disease

• Participants must not have bilateral invasive breast cancer

• Participants must not have inflammatory breast cancer

• Patients must not be pregnant or lactating

• Participants must not have a history of an excisional biopsy or lumpectomy performed prior to study entry

• Participants must not have previously received treatment with anthracyclines for any malignancy.

• Participants must not have received any treatment for currently diagnosed breast cancer prior to enrollment - including endocrine therapy, chemotherapy, targeted therapy, or radiation.

• Participants must not have a 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

• Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities, on assessment of left ventricular function.

• Participants must not have HIV, hepatitis B, or hepatitis C infections.

• Participants must not have a 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.

• Participants must not have any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.

• Participants must not have 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.