Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ki67 Expression in Tumors |
-40 | 0.0001 sig |
| SECONDARY Change in FACT-ES Symptom Scores |
1.5 | — |
| SECONDARY Number of Participants With Long Term Endocrine Therapy Adherence |
33 | — |
| SECONDARY Correlation Between Changes in Ki67 and Symptoms |
-0.02 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years old
- Diagnosed with hormone receptor positive invasive breast cancer (estrogen receptor (ER) or progesterone receptor (PR) or both >1%) by core needle biopsy
- Clinical American Joint Committee on Cancer (AJCC) 7th edition Stage 1 or 2
- Candidate for surgical therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2
- No chemotherapy or endocrine therapy for breast cancer in last 5 years
- Paraffin fixed core needle tissue block, or biopsy punch available for central analysis for proliferative markers
- Not pregnant or lactating and practicing adequate birth control if premenopausal
- Able and willing to provide informed consent
Exclusion Criteria
- Prior personal history of uterine cancer
- Prior personal history of stroke or deep vein thrombosis (DVT)
- Current therapy with strong CYP2D6 inhibitors The following medications should not be administered with tamoxifen (21 day treatment period) and will need to be stopped for the designated period of time prior to starting the study tamoxifen.
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Fluoxetine - should be discontinued 30 days prior to starting tamoxifen Paroxetine - should be discontinued 5 days prior to starting tamoxifen Sertraline - should be discontinued 5 days prior to starting tamoxifen Bupropion - should be discontinued 5 days prior to starting tamoxifen
- Concurrent coumarin-type anticoagulation therapy
- Any other contraindications to tamoxifen therapy
Data sourced from ClinicalTrials.gov (NCT01614210). 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.