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

NCT ID: NCT01917279

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2021-07-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intermittent Capecitabine

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.

Group Type: ACTIVE_COMPARATOR

Docetaxel plus Capecitabine

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

Docetaxel plus Capecitabine

Intervention Type: DRUG

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.

Metronomic Capecitabine

Intervention Type: DRUG

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Interventions

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.

Intervention Type: DRUG

Intermittent Capecitabine

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle

Intervention Type: DRUG

Metronomic Capecitabine

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Intervention Type: DRUG

Other Intervention Names

Xeloda; Xeloda

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Binghe Xu

UNKNOWN

Sponsor Role: lead

Responsible Party

Binghe Xu

Director of Medical Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Binghe Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Institute and Hospital, Chinese Academy Of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Binghe Xu, MD, PhD

Role: CONTACT

xubinghe@medmail.com.cn

+86-10-87788826

Fei Ma, MD

Role: CONTACT

mafei2011@139.com

+86-13910217780

Facility Contacts

Binghe Xu, MD, PhD

Role: primary

xubinghe@medmail.com.cn

+86-10-87788826

Fei Ma, MD

Role: backup

mafei2011@139.com

+86-13910217780

References

Yi Z, Feng K, Lv D, Guan Y, Shao Y, Ma F, Xu B. Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer. Signal Transduct Target Ther. 2024 Dec 9;9(1):345. doi: 10.1038/s41392-024-02047-0.

Reference Type: DERIVED

PMID: 39648226 (View on PubMed)

Guan X, Ma F, Li C, Wu S, Hu S, Huang J, Sun X, Wang J, Luo Y, Cai R, Fan Y, Li Q, Chen S, Zhang P, Li Q, Xu B. The prognostic and therapeutic implications of circulating tumor cell phenotype detection based on epithelial-mesenchymal transition markers in the first-line chemotherapy of HER2-negative metastatic breast cancer. Cancer Commun (Lond). 2019 Jan 3;39(1):1. doi: 10.1186/s40880-018-0346-4.

Reference Type: DERIVED

PMID: 30606259 (View on PubMed)

Other Identifiers

ML28898

Identifier Type: -

Identifier Source: org_study_id