EA1181: (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

About this Study

The purpose of this study is to see how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy.

Sponsor Protocol ID:EA1181
IRB Number:2020-0136
Actively Enrolling
Interventional
Phase 2
June 30, 2022
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
No

Inclusion Criteria
  • Histologically confirmed HER positive primary invasive breast carcinoma
  • Hormone receptors must be known
  • Stage II or IIIa¬†
  • Bilateral invasive breast cancers are eligible, if both cancers are HER2 positive

Exclusion Criteria
  • Must be able to make decisions
  • Must not have history of any prior (ipsilateral or contralateral) invasive breast cancer
  • Must not have prior ipsilateral ductal breast carcinoma in situ (DCIS)
  • Must not have stage IV ( metastatic) breast cancer
  • No prior treatment for current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy
  • No concurrent serious medical condition, uncontrolled hypertension, cardiovascular disease, cerebrovascular accident/stroke or myocardial infarction within 6 month prior to registration, unstable angina, congestive heart failure (CHF) or serious cardiac arrhythmia requiring medication
  • Must not be pregnant or breast-feeding

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Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jessie Solise
Phone Number: 601-984-1963
Email: jsolise@umc.edu
Principal Investigator:Tang, Shou J, M.D.
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