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

NCT02011880 | Unknown

• 1 other identifier: ZYSNXD-CC-ZDYJ043
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Bone Metastasis

Keywords

breast cancer; bone metastasis; traditional Chinese medicine(TCM)

Interventions

Chinese Herbs DIETARY_SUPPLEMENT

Dietary Supplement:Experiment group: Fructus Cnidii,Psoralea Corylifolin L.，monkshood -Granules,Oral(add into the breast cancer postoperative prescription solution),A Pack(Fructus Cnidii 9g，Psoralea Corylifolin L. 15g，monkshood 9g),Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity Breast Cancer Postoperative Prescription -Water Decoction,Oral,200ml,Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity Dietary Supplement:Contrast Group: Breast Cancer Postoperative Prescription -Water Decoction,Oral,200ml,Bid Days,3 Periods( a month is a period),Until progression/unacceptable toxicity

Also known as: Fructus Cnidii, Psoralea Corylifolin L., monkhsood, Breast Cancer Postoperative Prescription

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Last Updated: December 13, 2013

Record last verified: 2013-09