Phase 2
N=35
Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country
Breast Cancer · Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02806544 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility — 35 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tamoxifen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Vanderbilt University
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility |
35 | — |
| SECONDARY Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen |
13 | — |
| SECONDARY Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy |
15 | — |
| SECONDARY Overall Clinical Response Rate |
13 | — |
| SECONDARY Pathologic Complete Response |
1 | — |
| SECONDARY Breast Conserving Therapy |
— | — |
Summary
This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.
Eligibility Criteria
Inclusion Criteria
- Patient evaluated and treated at INCAN
- Patients must provide informed consent
- Patient must be ≥ 18 years of age.
- Life expectancy ≥ 6 months
- Clinical locally advance breast cancer (Stage IIB or III)
- Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4
- Patient must have an ECOG Performance Status of 0-2
- Patients must be able to swallow and retain oral medication
Exclusion Criteria
- Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years
- Patient must not be pregnant or nursing
- Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
- Women of childbearing age unable or unwilling to use contraception
Data sourced from ClinicalTrials.gov (NCT02806544). 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.