Clinical trial · Interventional
Preoperative Window of Endocrine Therapy Provides Information to Increase Compliance
NCT01614210CI-TRIAL-00034088POWER PIINCcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to see if tumors respond to endocrine therapy by taking a total of 21 doses of Tamoxifen before and after surgery. Tamoxifen is currently approved by the FDA (Food and Drug Administration) for use in the treatment of hormone positive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Hormone Positive Clinical Stage 1 or 2 Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast cancer surgery | Procedure | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- All patients enrolled in the study.
- interventionNames
- Drug: Tamoxifen
- Procedure: Breast cancer surgery
Primary outcomes (1)
- measure
- Change in Ki67 Expression in Tumors
- timeFrame
- 7 days
- description
- Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.
Secondary outcomes (3)
- measure
- Change in FACT-ES Symptom Scores
- timeFrame
- 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.