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

Breast Neoplasms Clinical Trial

— CAMELLIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01917279
• Other study ID #: ML28898
• Status: Recruiting
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: July 2021

Study information

• Verified date: July 2020
• Source: Chinese Academy of Medical Sciences
• Contact: Binghe Xu, MD, PhD
• Phone: +86-10-87788826
• Email: xubinghe[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Docetaxel plus Capecitabine
Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration. For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.
• Intermittent Capecitabine
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
• Metronomic Capecitabine
Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy Of Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Binghe Xu	Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Time from randomization to progression or death (whichever occurred first).	up to 36 months
Secondary	Adverse events (AEs)	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.	up to 36 months
Secondary	Overall survival (OS):	Time from randomization to death	up to 52 months
Secondary	Overall Response rates (ORR)	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.	up to 36 months
Secondary	Clinical Benefit rate (CBR)	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	up to 36 months
Secondary	Time to Progression (TTP)	Time from randomization to disease progression	up to 36 months
Secondary	QoL	Using the EORTC quality of life questionnaire QLQ-C30	up to 36 months