Clinical trial · Interventional
A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer(Overstep)
NCT02597868CI-TRIAL-00021533unknownN/AClinicalTrials.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)
A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
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 |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| endocrine therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Capecitabine
- description
- Capecitabine 1250mg per BSA by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- endocrine therapy
- description
- endocrine therapy is be gived as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemotreatment,the medcine will be confirmed by the patient's past-treatment.
- interventionNames
- Procedure: endocrine therapy
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * The age is Above 18 years of age, \<70 years old * HR-positive \& HER2-negative * Metastatic breast cancer,incurable. * No prior chemotherapy for metastatic recurrence, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy as first-line treatment for metastatic lesions * Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~1 * The basic function of normal bone marrow * Functions of liver and kidney is normal * Expectation of life is more than 3 months * Agreed to take contraceptive measures during treatment Exclusion Criteria: * Previous toxicity was not recovered to 0-1 degrees * Central nervous system metastasis * Pregnancy or lactation * There are uncontrolled infection, myocardial infarction, thrombosis, etc. * There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease; * Researchers believe that is not suitable for the study * Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix; * Bilateral breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.