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Early Breast Cancer Treatment Response Study

This study is looking at whether how much a breast cancer tumor shrinks before surgery (called clinical response) can predict how much cancer is left after surgery (called pathologic response). You may be eligible if you are at least 18 years old, male or female, and have invasive breast cancer that is triple-negative, HER2-positive, or high-risk estrogen receptor positive. Participants will receive chemotherapy treatments including Paclitaxel, Carboplatin, Trastuzumab, Pertuzumab, and Doxorubicin. The study aims to see if early tumor shrinkage can help doctors understand how well a treatment is working, potentially leading to more personalized care in the future. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 185 participants. It is not specified if it is randomized, blinded, or what phase it is.
What's involved
You would receive chemotherapy treatments over several cycles. Your tumor measurements would be taken at the beginning of the study and again at the time of surgery, which occurs after 20 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your tumor response will be measured at baseline and at surgery, which occurs after 20 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05020860

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Baylor Breast Care Center
~185 participants
Updated 2025-02-27 on ClinicalTrials.gov
What's tested:PaclitaxelCarboplatinTrastuzumabPertuzumabDoxorubicinCyclophosphamide

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Clinical Tumor Measurement vs. Pathologic Response
Measured over Baseline and at surgery (after 20 weeks)

Conditions

Breast Cancer
Breast Neoplasm
Breast Cancer Female
Breast Cancer Invasive
Breast Cancer Stage II
Breast Cancer Stage III
Triple Negative Breast Cancer
Hormone Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Neoplasms
Estrogen Receptor-positive Breast Cancer

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Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Mothaffar Rimawi, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Maria Rodriguez
[email protected]
(713) 798-8347
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).
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

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.

What this trial measures

  • Change in Clinical Tumor Measurement vs. Pathologic ResponseBaseline 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.