Clinical trial · Interventional
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women
NCT00186121CI-TRIAL-00041020completedPhase 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)
To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of the breast.
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 |
|---|---|---|---|
| Anastrozole (Arimidex) | Drug | Anastrozole | ALIAS |
| Goserelin (Zoladex) | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anastrozole + Goserelin
- description
- Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.
- interventionNames
- Drug: Anastrozole (Arimidex)
- Drug: Goserelin (Zoladex)
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 3 months
- description
- ORR was determined as the sum of the Complete Response (CR) rate + Partial Response (PR) rates. * CR = Complete disappearance of all clinically- or pathologically-detectable malignant disease for at least 4 weeks. * PR = ≥ 50% decrease in tumor size for at least 4 weeks, without any new lesion or any ≥ 25% increase in size of any lesion. All measurements by ruler or calipers.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
INCLUSION CRITERIA * Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive * Premenopausal, defined as any of: 1. Last menstrual period within 3 months, or 2. Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or, 3. If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range * Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Granulocytes \> 1500/mm\^3 * Platelets \> 100,000/mm\^3 * Serum glutamic oxaloacetic transaminase (SGOT) \< 2.5 x upper limit of normal * Total bilirubin \< 1.5 mg/dL * May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response. * Must be using effective contraception or not be of childbearing potential * Signed written informed consent INCLUSION CRITERIA * Active, unresolved infection * Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years * Prior treatment with an aromatase inhibitor or inactivator * Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist * Adjuvant chemotherapy within 6 months of study entry. * Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment * Central nervous system metastasis * Lymphangitic pulmonary metastasis * Pregnant or lactating
References
Publications (1)
- RESULTCarlson RW, Theriault R, Schurman CM, Rivera E, Chung CT, Phan SC, Arun B, Dice K, Chiv VY, Green M, Valero V. Phase II trial of anastrozole plus goserelin in the treatment of hormone receptor-positive, metastatic carcinoma of the breast in premenopausal women. J Clin Oncol. 2010 Sep 1;28(25):3917-21. doi: 10.1200/JCO.2009.24.9565. Epub 2010 Aug 2. PMID 20679610