Clinical trial NCT01917279: Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Neoplasms
Neoplasms by Site
Neoplasm Metastasis
Breast Diseases
Skin Diseases
Keywords: Metastatic Breast Cancer
Antineoplastic Agents
Therapeutic Uses
Antimetabolites
Tubulin Modulators
Maintenance chemotherapy
Metronomic chemotherapy
Capecitabine
Docetaxel
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Hoffmann-La Roche
First posted: 2013-08-06
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: up to 36 months
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: up to 36 months
measure: Overall survival (OS):
timeFrame: up to 52 months
measure: Overall Response rates (ORR)
timeFrame: up to 36 months
measure: Clinical Benefit rate (CBR)
timeFrame: up to 36 months
measure: Time to Progression (TTP)
timeFrame: up to 36 months
measure: QoL
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy Of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Binghe Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.