Clinical trial · Interventional
Maintenance Hormone Therapy for Postmenopausal HR Positive Advanced Breast Cancer
Maintenance Hormone Therapy With Fulvestrant After First-Line Chemotherapy for Postmenopausal Hormone-receptor-positive (HR) Positive Advanced Breast Cancer: A Multicenter, Prospective Phase II Study
NCT02000193CI-TRIAL-00033696FANCYunknownPhase 2ClinicalTrials.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)
This is a prospective, single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer.
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 |
|---|---|---|---|
| fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- drug: Fulvestrant treatment : Eligible patients will receive fulvestrant 500 mg intramuscular injection on day 1, 15, 29, then every 28 days. The treatment will continue until disease progression or intolerable adverse event
- interventionNames
- Drug: fulvestrant
Primary outcomes (1)
- measure
- Clinical Benefit Rate
- timeFrame
- 1 year
- description
- defined as the proportion of all treated patients who have a best objective tumour response of CR, PR or SD ≥ 24 weeks
Secondary outcomes (3)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: Provision of informed consent Histologically proven HR positive breast cancer Postmenopausal woman, defined as a woman fulfilling any 1 of the following criteria (based on the NCCN definition of menopause \[National Comprehensive Cancer Network 2008\]): Prior bilateral oophorectomy Age ≥60 years Age \<60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone and oestradiol in the postmenopausal range. Patients have completed first-line chemotherapy for metastatic breast cancer The first-line chemotherapy must be given to patients with visceral disease or progressive disease requiring a fast response Responded(CR or PR) or stabilized(SD\>=24 weeks) to first-line chemotherapy for metastatic breast cancer The duration of 1st line chemotherapy for advanced breast cancer had been at least 4 cycles and at most 8 cycles WHO performance status 0, 1 or 2- Exclusion Criteria: * Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present) Prior hormonal treatment for metastatic breast cancer are not allowed More than one line of cytotoxic chemotherapy for metastatic breast cancer Her-2 positive Other malignant tumor (concurrent or previous). Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the study protocol, eg, uncontrolled cardiac disease or uncontrolled diabetes mellitus
References
Publications (0)
Data not yet available
No reference posted for this study.