A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery (NCT05549505) | Clinical Trial Compass
CompletedPhase 2
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
United States152 participantsStarted 2023-02-15
Plain-language summary
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Post-menopausal females ≥ 18 years.
* Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment). ER and HER2 status must be documented:
* ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by immunohistochemistry (IHC) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
* HER2- disease by either IHC or in situ hybridization per ASCO/CAP guidelines.
* Ki-67 score ≥ 5%, analyzed locally.
* Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer.
* The primary tumor must be at least 1.5 cm by imaging.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection.
Exclusion Criteria:
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
* Any of the following in the previous 6 months: Myocardial infarction; Severe unstable angina; Coronary/peripheral artery bypass graft; Symptomatic congestive heart failure (New York Heart Association class III or IV); Cerebrovascular accident; Transient ischemic attack; Symptomatic pulmonary embolism or other clinically significant episode of thromboembolism.
* Any of the following in the previous 6 months: Co…
What they're measuring
1
Percent Reduction in Ki-67 Expression From Baseline to Day 15 in Tumor Biopsies
Timeframe: Baseline (during screening, prior to Day 1) and Day 15