Clinical trial · Interventional
High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Data Monitoring Committee recommended closure due to poor accrual.
Summary
Brief summary (as posted)
RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy. PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| esterified estrogens | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Clinical response rate
Secondary outcomes (2)
- measure
- Time to disease progression
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Metastatic disease
* Documented disease progression
* Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer
* Disease progression during adjuvant tamoxifen is considered 1 prior therapy
* The 2 most recent treatments must have been endocrine agents
* At least 1 objective measurable disease parameter
* Brain metastases allowed provided both of the following criteria are met:
* Brain metastases were previously treated AND are currently stable
* Brain metastases are not the only site of metastatic disease
* Hormone receptor status
* Estrogen and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Postmenopausal, as defined by any of the following:
* At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months
* At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range
* Under 50 years of age and FSH level within postmenopausal range
* Prior bilateral oophorectomy
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* Adequate hematologic function
Hepatic
* Adequate hepatic function
* Bilirubin ≤ 1.5 times upper limit of normal
* No history of hepatic adenoma
Renal
* Adequate renal function
* No history of hypercalcemia or severe hypocalcemia
Cardiovascular
* No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use
* No active thrombophlebitis or thromboembolic disorders
* No history of uncontrolled hypertension
Other
* Not pregnant
* No undiagnosed abnormal vaginal bleeding
* No other serious medical illness
* No psychiatric illness that would preclude giving informed consent
* No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Prior chemotherapy for metastatic disease allowed
* Prior adjuvant chemotherapy allowed
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* Prior radiotherapy allowed provided the only site of measurable disease was not irradiated
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available