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

Expanded access is temporarily not available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT02011880
First received: December 10, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted

December 10, 2013
December 10, 2013
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Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer

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.

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.

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  • Breast Cancer
  • Bone Metastasis
Dietary Supplement: 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

Other Names:
  • Fructus Cnidii
  • Psoralea Corylifolin L.
  • monkhsood
  • Breast Cancer Postoperative Prescription
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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.
Female
20 Years to 70 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT02011880
ZYSNXD-CC-ZDYJ043
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Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
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Shanghai University of Traditional Chinese Medicine
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP