Understanding how tumor shrinkage predicts cancer response in early breast cancer patients
A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer
This study tests if measuring how much breast tumors shrink during chemotherapy can help predict how well the treatment will work for women with early-stage breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 185 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Breast Care Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT05020860 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed invasive breast cancer, specifically those who are triple-negative, HER2-positive, or high-risk estrogen receptor positive.
Not a fit: Patients with non-invasive breast cancer or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for breast cancer patients, improving outcomes and reducing unnecessary therapies.
How similar studies have performed: Previous studies have shown promising results in correlating clinical and pathologic responses in breast cancer, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.