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

Last updated: December 10, 2013
Sponsor: Shanghai University of Traditional Chinese Medicine
Overall Status: Trial Not Available

Phase

N/A

Condition

Breast Cancer

Neoplasm Metastasis

Cancer

Treatment

N/A

Clinical Study ID

NCT02011880
ZYSNXD-CC-ZDYJ043
  • Ages 20-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ofChongRen 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

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 Start date:
Estimated Completion Date:

Study 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.