Overview

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.