A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer (CAMELLIA)

NCT01917279 Phase 3 UNKNOWN

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).

Details

Lead sponsor	Binghe Xu
Phase	Phase 3
Status	UNKNOWN
Enrolment	280
Start date	2013-10
Completion	2021-07

Conditions

• Breast Neoplasms
• Neoplasms by Site
• Neoplasm Metastasis
• Breast Diseases
• Skin Diseases

Interventions

• Docetaxel plus Capecitabine
• Intermittent Capecitabine
• Metronomic Capecitabine

Primary outcomes

• Progression Free Survival (PFS) — up to 36 months
  Time from randomization to progression or death (whichever occurred first).

Countries

China