Phase 2
N=35
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00186121 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Objective Response Rate (ORR) — 37.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anastrozole (Arimidex) (Drug); Goserelin (Zoladex) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
37.5 | — |
| SECONDARY Clinical Benefit Rate |
71.9 | — |
| SECONDARY Response Rates |
1; 11; 11 | — |
| SECONDARY Time-to-Progression (TTP) |
8.3 | — |
| SECONDARY Overall Survival (OS) |
NA | — |
| SECONDARY Estradiol Suppression |
74.7; 20.8; 18.7; 14.8 | — |
| SECONDARY Serious Adverse Events |
— | — |
Summary
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.
Eligibility Criteria
INCLUSION CRITERIA
- Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive
- Premenopausal, defined as any of:
- Last menstrual period within 3 months, or
- Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,
- 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
Data sourced from ClinicalTrials.gov (NCT00186121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.