Overview

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

Status:
Recruiting
Trial end date:
2021-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Binghe Xu
Collaborator:
Hoffmann-La Roche
Treatments:
Capecitabine
Docetaxel
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.