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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Docetaxel and Cyclophosphamide (TC); Drug: Docetaxel (T)

Study type: Interventional

Funder types: Other

Identifiers

NCT01526499

TCvsT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

TC

Experimental group

Description:

Docetaxel plus Cyclophosphamide

Treatment:

Drug: Docetaxel and Cyclophosphamide (TC)

T

Active Comparator group

Description:

Docetaxel

Treatment:

Drug: Docetaxel (T)