Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer

NCT ID: NCT01526499

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-07-31

Brief Summary

The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Detailed Description

Metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. This trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.

Conditions

Breast Cancer

Study Design

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

Study Groups

TC

Docetaxel plus Cyclophosphamide

Group Type: EXPERIMENTAL

Docetaxel and Cyclophosphamide (TC)

Intervention Type: DRUG

Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days

T

Docetaxel

Group Type: ACTIVE_COMPARATOR

Docetaxel (T)

Intervention Type: DRUG

Docetaxel 75mg/m2 IVGTT D1;every 21days

Interventions

Docetaxel and Cyclophosphamide (TC)

Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days

Intervention Type: DRUG

Docetaxel (T)

Docetaxel 75mg/m2 IVGTT D1;every 21days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Females with age between 18 and 70 years old

2. ECOG performance between 0-1

3. Life expectancy more than 3 months

4. Histological proven unresectable recurrent or advanced breast cancer

5. No previous chemotherapy for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year).

6. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)

7. No anticancer therapy within 4 weeks

8. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney

9. Provision of written informed consent prior to any study specific procedures

Exclusion Criteria

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)

2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study

3. Treatment with an investigational product within 4 weeks before the first treatment

4. Symptomatic central nervous system metastases

5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

6. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions

7. Uncontrolled serious infection

8. Patients with bad compliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

yanfei Liu

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhonghua Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Leiping Wang, MD

Role: CONTACT

leipingwang@163.com

+862164175590

Facility Contacts

Leiping Wang, MD

Role: primary

leipingwang@163.com

+862164175590 ext. 8908

Other Identifiers

TCvsT

Identifier Type: -

Identifier Source: org_study_id