Understanding how tumor shrinkage predicts cancer response in early breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether the clinical response of breast tumors to neoadjuvant chemotherapy can predict the pathologic response observed during surgery. Participants with early-stage invasive breast cancer will receive a combination of chemotherapy agents, and their tumor size will be measured through imaging and physical exams. The goal is to identify early predictors of pathologic complete response (pCR), which could help tailor treatments and avoid ineffective therapies. By correlating clinical and pathologic responses, the study aims to enhance treatment strategies for breast cancer patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Harris Health System - Smith Clinic
  Houston, Texas, United States Recruiting
• O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Mothaffar Rimawi, MD — Baylor College of Medicine
• Study coordinator: Maria Rodriguez
• Email: bcc-clinicalresearch@bcm.edu
• Phone: (713) 798-8347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.