Actively Recruiting
A Phase II Trial Correlating Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Early Stage Breast Cancer
Led by Baylor Breast Care Center · Updated on 2025-02-27
185
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the amount a breast tumor shrinks during chemotherapy before surgery can predict the amount of tumor left at surgery in patients with early breast cancer. This study focuses on three breast cancer subtypes: triple-negative breast cancer (TNBC), HER2-positive, and high-risk estrogen receptor-positive breast cancer. The goal is to find early signs of how well the tumor responds to treatment to help tailor therapy in the future and avoid ineffective treatments. Participants receive standard chemotherapy regimens over about 20 weeks, including combinations of drugs such as paclitaxel, carboplatin, doxorubicin, cyclophosphamide, trastuzumab, pertuzumab, and pembrolizumab depending on cancer subtype. Some participants with TNBC will have extra research procedures like biopsies and MRI scans before and after the first cycle of treatment to study tumor changes. Treatment includes four cycles of one drug combination followed by four cycles of another. Participants will have tumor size measured by imaging and physical exam at baseline and after treatment cycles to track response. Surgery is performed after treatment to assess the remaining tumor. Researchers will compare early tumor shrinkage to the final pathological response at surgery. Safety, organ function, and heart health are monitored throughout. The study duration is about 20 weeks until surgery, with assessments planned to evaluate how early clinical changes relate to final outcomes.
CONDITIONS
Brief Title
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old and legally able to consent
- Both men and women are eligible
- Histologically confirmed invasive breast cancer of triple negative, HER2-positive, or high-risk estrogen receptor-positive subtype
- For high-risk estrogen receptor-positive, must meet at least 2 criteria: grade 3 tumor, age 50 or less, low ER Allred score, or high Ki-67
- Tumor size at least 2 cm by clinical exam or ultrasound
- Bilateral breast cancers allowed if one lesion is designated for study and same treatment applies
- ECOG performance status 0 or 1
- Left ventricular ejection fraction above institutional lower limit
- Adequate organ function per specified blood count and chemistry thresholds
- Willing to use effective, non-hormonal contraception if of childbearing potential
- Participation in another trial allowed with approval
You will not qualify if you...
- Evidence of stage IV breast cancer
- Inflammatory breast cancer
- Pregnant or lactating
- Prior excisional biopsy or lumpectomy before study entry
- Prior anthracycline treatment for any cancer
- Prior treatment for current breast cancer diagnosis
- History of significant cardiac disease that prevents use of study drugs
- Current HIV, hepatitis B, or hepatitis C infection
- Recent non-breast malignancies within 5 years except certain skin or in situ cancers
- Other systemic diseases preventing treatment or follow-up
- Psychiatric, addictive, social, or medical conditions preventing meeting study needs
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 weeks
Participants receive neoadjuvant systemic therapy with combinations of chemotherapy and targeted drugs according to their breast cancer subtype. Treatment includes cycles of paclitaxel, carboplatin, trastuzumab, pertuzumab, doxorubicin, cyclophosphamide, and pembrolizumab as appropriate.
Weekly visits for up to 12 weeks during initial treatment cycles, then visits every 2 to 3 weeks during subsequent cycles
Duration - 1 day
After completing neoadjuvant therapy, participants undergo surgery to remove breast tumors and assess pathologic response to treatment.
1 visit (in-person) for surgery
Trial Site Locations
Total: 2 locations
1
Harris Health System - Smith Clinic
Houston, Texas, United States, 77054
Actively Recruiting
2
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
M
Maria Rodriguez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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