Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

Phase 3

• Conditions: Skin Diseases; Neoplasm Metastasis; Neoplasms by Site; Breast Neoplasms; Breast Diseases
• Interventions: Drug: Docetaxel plus Capecitabine; Drug: Intermittent Capecitabine; Drug: Metronomic Capecitabine

• Registration Number: NCT01917279
• Lead Sponsor: Binghe Xu

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-08-04
• Study First Posted: 2013-08-06
• Study Start: 2013-10
• Status Verified: 2020-07
• Primary Completion: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Signed informed consent obtained prior to initiation of any study-specific procedures or treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
• Female patients aged ≥ 18 years.
• Histologically confirmed and documented HER2-negative metastatic breast cancer.
• Previously untreated first-line chemotherapy.
• Patients with at least one measurable lesion according to RECIST criteria at study entry.
• Documented ER/PgR status.
• Prior hormone therapy for metastatic disease is allowed but must stop before study entry.
• KPS>70.
• Life expectancy of ≥12 weeks

Exclusion Criteria

• Previous chemotherapy for metastatic breast cancer.

• Prior adjuvant/neoadjuvant chemotherapy within 6 months prior to first study treatment administration.

• Prior (radical)radiotherapy for the treatment of metastatic disease or major surgical procedure within 28 days prior to the first study treatment,

• Inadequate bone marrow function: absolute neutrophil count (ANC): <1.5 x 109/L, platelet count<75 x 109/L or hemoglobin <100g/L.

• Inadequate liver or renal function, defined as:

  1. Serum (total) bilirubin >2 x the upper limit of normal (ULN) for the institution
  2. AST/SGOT or ALT/SGPT >2.5 x ULN (>5 x ULN in patients with liver metastases)
  3. ALP >2.5 x ULN at baseline (>5 x ULN in patients with liver metastases).
  4. Serum creatinine>140umol/L.

• Pregnant or lactating females.

• Her-2 positive (ICH +++ or FISH positive).

• Symptomatic cerebral parenchyma and/or leptomeningeal metastases.

• Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.

• Pre-existing peripheral neuropathy ≥grade 1 according NCI CTCAE 4.0.

• Mental disease or other conditions affecting on the compliance of patients.

• Other serious disease or medical condition:

  1. History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent.
  2. Congestive heart failure, or unstable angina, myocardial infarction within ≤6 months prior to the first study treatment, uncontrolled hypertension and high risk, uncontrolled arrhythmias.
  3. Uncontrolled acute infection

• Inability to take or absorption oral medications.

• Concurrent or within 30 days using drugs of other clinical trials.

• Previous treatments containing Capecitabine (whether adjuvant or palliative treatment).

• Previous treatments containing docetaxel within 12 months.

• Known hypersensitivity to any of the study treatments or excipients.

• Any other conditions the research consider not appropriate to take part in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronomic Capecitabine	Docetaxel plus Capecitabine	Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
Intermittent Capecitabine	Docetaxel plus Capecitabine	Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.
Intermittent Capecitabine	Intermittent Capecitabine	Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.
Metronomic Capecitabine	Metronomic Capecitabine	Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)	up to 36 months	Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0), premature withdrawals and vital signs. Hand-foot syndrome and diarrhea will be specially interested.; Adverse events of special interest: hand-foot syndrome and diarrhea. The estimated HFS rate will be about 60% from intermittent Capecitabine vs about 10% from metronomic Capecitabine, diarrhea rate will be about 50% from intermittent Capecitabine vs about 10% from metronomic Capecitabine.
Overall survival (OS):	up to 52 months	Time from randomization to death
Overall Response rates (ORR)	up to 36 months	Defined as CR+PR, assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase.
Clinical Benefit rate (CBR)	up to 36 months	Defined as CR+PR+SD, assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase
Time to Progression (TTP)	up to 36 months	Time from randomization to disease progression
QoL	up to 36 months	Using the EORTC quality of life questionnaire QLQ-C30

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy Of Medical Sciences; 🇨🇳 Beijing, China