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

Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Breast Diseases; Skin Diseases

Intervention: Docetaxel plus Capecitabine (Drug); Capecitabine (Drug); Capecitabine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Binghe Xu

Official(s) and/or principal investigator(s):
Binghe Xu, MD, PhD, Principal Investigator, Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Overall contact:
Binghe Xu, MD, PhD, Phone: +86-10-87788826, Email: xubinghe@medmail.com.cn

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival (PFS)

Secondary outcome:

Adverse events (AEs)

Overall survival (OS):

Overall Response rates (ORR)

Clinical Benefit rate (CBR)

Time to Progression (TTP)

QoL

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Binghe Xu, MD, PhD, Phone: +86-10-87788826, Email: xubinghe@medmail.com.cn

Cancer Institute and Hospital, Chinese Academy Of Medical Sciences, Beijing 100021, China; Recruiting
Binghe Xu, MD, PhD, Phone: +86-10-87788826, Email: xubinghe@medmail.com.cn
Fei Ma, MD, Phone: +86-13910217780, Email: mafei2011@139.com
Binghe Xu, MD, PhD, Principal Investigator
Fei Ma, MD, Sub-Investigator
Additional Information

Starting date: October 2013
Last updated: November 21, 2013

Page last updated: August 23, 2015

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