Clinical trial · Interventional
Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
Comparison in the Change of Proliferation Index Between Fulvestrant and Tamoxifen in Cyclin D1 +, Estrogen Receptor + Breast Cancer
NCT02936206CI-TRIAL-00051883terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual rate
Summary
Brief summary (as posted)
The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal and post-menopausal women before and after exposure to one of the two commonly used breast cancer drugs, tamoxifen or fulvestrant.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fulvestrant
- description
- 750 mg injection in 3 divided doses
- interventionNames
- Drug: Fulvestrant
- type
- ACTIVE_COMPARATOR
- label
- Tamoxifen
- description
- 20mg orally
- interventionNames
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Change in Ki67 Cell Percentage
- timeFrame
- baseline and 2 weeks
- description
- The change in proliferation index as measured by the percentage of cells staining for Ki67 at 2 weeks as compared on baseline.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the study treatment regimen and follow-up, must be obtained and documented according to the local regulatory requirements * Adult women greater than 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * New diagnosis of invasive cyclin D1 +, ER+, PR +/-, Her2- breast cancer * Cyclin D1 positive as defined as a total immunohistochemical score of 5 or greater * Hormone receptor positive as defined as ≥ 10% positive stained cells * HER2-normal (IHC score 0-1 or FISH negative \[in-situ hybridization (ISH) ratio \<= 2.0 status\]) * Tumor size at least 5 mm with planned primary surgery at Mount Sinai * A negative urine dipstick pregnancy test Exclusion Criteria: * Estrogen receptor negative invasive breast carcinoma as defined as less than 10% stained cells * Prior antiestrogen therapy * Tumor size less than 5 mm * Prior diagnosis of thrombosis or known hypercoagulable state * Known history of bleeding diathesis * Known liver disease * Prior treatment with neoadjuvant therapy * Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema). * Current severe or uncontrolled systemic disease * Pregnancy or lactation period. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices) during study treatment. * Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.
References
Publications (0)
Data not yet available
No reference posted for this study.