Phase 2
Completed N=42
Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.
Source: ClinicalTrials.gov NCT00921115 ↗Enrolled (actual)
42
Serious AEs
9.5%
Results posted
May 2017
Primary outcomePrimary: Pathologic Complete Response (PCR) Rate — 0 participants
Summary
This study is being done to test the safety and effectiveness of two drugs, Anastrozole and Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor positive invasive breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response (PCR) Rate |
— | — |
Eligibility Criteria
Inclusion criteria
- Female patient > 18 years of age.
- Histologically proven invasive adenocarcinoma of the breast.
- Patients must be candidates for neoadjuvant treatment (Tumor size > 2cm and/or clinical N1 or N2).
- ER positive (> 10% of cells) and/or PgR positive (> 10% of the cells) and HER-2 negative disease (IHC 0 or 1+ and/or FISH negative, IHC 2+ and FISH negative)
- Menopausal status
- Patients must be post-menopausal as defined by one of the following criteria:
- Prior bilateral oophorectomy
- 12 months since LMP with no prior hysterectomy
- Patients > 55 years with prior hysterectomy
- Patients 25.
Data sourced from ClinicalTrials.gov (NCT00921115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.