Know Cancer

forgot password

Phase 2
18 Years
70 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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.

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Zhonghua Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

December 2011

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • Metronomic cyclophosphamide
  • metastatic breast cancer
  • first line
  • docetaxel
  • Breast Neoplasms