Clinical trial · Interventional
Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy
A Single Arm Phase II Study of Pharmacologic Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
NCT00661531CI-TRIAL-00026932terminatedPhase 2Results 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): Poor accrual
Summary
Brief summary (as posted)
This trial seeks to confirm the response rate for estrace treatment in a patients with hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine therapies.
Conditions
Conditions (3)
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 |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Estrace | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Estrace & Anastrozole
- description
- Estrace 10 mg three times a day for 3 months. After 3 months of estrace, the estrace will be stopped and anastrazole 1 mg daily will be administered
- interventionNames
- Drug: Estrace
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 6 months
- description
- Progression free survival is defined as the time from assignment of treatment to the time of disease progression or death from any cause
Secondary outcomes (1)
- measure
- Response Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer metastatic breast cancer * Clinically determined evaluable disease * Post-menopausal woman * Previous clinical benefit from prior anti-estrogen therapies and subsequent failure of at least 2 prior endocrine therapies. * May have had chemotherapy for adjuvant \&/or metastatic disease. * May have had radiation therapy but not to the only site of disease. * Ecog performance status \</= 2. * Life expectancy of \> 6 months Exclusion Criteria: * Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical trial * Brain metastasis * Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary embolus * Current vaginal bleeding * Hypercalcemia or hypocalcemia * History of or active hepatic adenoma * No other malignancies within the past 5 years with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
References
Publications (0)
Data not yet available
No reference posted for this study.