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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TEMPORARILY_NOT_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Breast Cancer Bone Metastasis

Keywords

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breast cancer bone metastasis traditional Chinese medicine(TCM)

Interventions

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Chinese Herbs

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Fructus Cnidii Psoralea Corylifolin L. monkhsood Breast Cancer Postoperative Prescription

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ZYSNXD-CC-ZDYJ043

Identifier Type: -

Identifier Source: org_study_id