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Phase 2
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information


Metronomic chemotherapy has been considered as an effective strategy in metastatic breast
cancer. This trial is designed to evaluate the role of low dose metronomic cyclophosphamide
and capecitabine in pretreated metastatic breast cancer.


Inclusion Criteria:



1. Females with age between 18 and 80 years old

2. ECOG performance between 0-3

3. Life expectancy more than 3 months

4. Histological proven unresectable recurrent or advanced HER2-negative breast cancer

5. At least one previous therapy regimen (including endocrine therapy) 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

10. Previous capecitabine is permitted, however, it should be completed at least 6
months.

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

9. Patients lack of Dihydropyrimidine Dehydrogenase(DPD)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Zhonghua Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

metroCX

NCT ID:

NCT01526512

Start Date:

December 2011

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • Metronomic cyclophosphamide
  • Metronomic capecitabine
  • HER2-negative breast cancer
  • Breast Neoplasms

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