Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer

• Conditions: Breast Cancer; Bone Metastasis

• Registration Number: NCT02011880
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

The purpose of this clinical research study is to learn if the clinical effects of combined Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

Detailed Description

OBJECTIVES:

* Evaluate the effect of the Chinese herbal medicine on relieving the bone pain for patients with breast cancer bone metastasis.

* Evaluate the effect of the Chinese herbal medicine on improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OUTLINE: This is a randomized,multicentric, placebo-controlled, double-blind study. Patients are dynamic randomized to one of two treatment arms.

* Arm I:Patients receive traditional Chinese medicine(trial drugs) and endocrine therapy for 3 months.

* Arm II:Patients receive placebo and endocrine therapy for 3 months. All patients will be followed up for another 3 months with the trial drugs and endocrine therapy.

According to the sample size estimate:There are 296 patients (148 per treatment arm)will be collected in this trial.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-13
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: TEMPORARILY_NOT_AVAILABLE
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically confirmed breast cancer and hormone receptor positive.
• Bone metastasis and have a measurable foci.
• TCM syndrome type is deficiency of both vital energy and Yin ;maladjustment of ChongRen with deficiency Yang syndrome.
• The Karnofsky score ≥60.
• VAS score ≥3.
• Expected survival at least 6 months or greater.
• Age between 20 to 70(include 20 and 70).
• The function of cardiovascular,hepar,renal and hematopoieses is relatively normal.

Exclusion Criteria

• Women during the pregnancy or breast feeding.
• With a cardiovascular,hepar,renal,hematopoieses or other serious complications.
• Be allergic to the trial drugs.
• Participating in other trials.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified