Breast CancerNCT02011880
Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
A study testing Chinese Herbs in people with Breast Cancer and Bone Metastasis, run by Shanghai University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Bone Metastasis
- What is being tested?
- Chinese Herbs
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Bone Metastasis
- Being tested
- Chinese Herbs
- Keywords
- breast cancer, bone metastasis, traditional Chinese medicine(TCM)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese HerbsDietary supplement
Also called Fructus Cnidii, Psoralea Corylifolin L., monkhsood, Breast Cancer Postoperative Prescription
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011880
- Sponsor's protocol ID
- ZYSNXD-CC-ZDYJ043
- Status last verified
- Sep 2013
- First submitted
- 10 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT02011880
- Acronym / sponsor ID
- ZYSNXD-CC-ZDYJ043
- Conditions
- Breast Cancer, Bone Metastasis
- Keywords
- breast cancer, bone metastasis, traditional Chinese medicine(TCM)
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese HerbsAlso: Fructus Cnidii, Psoralea Corylifolin L., monkhsood, Breast Cancer Postoperative PrescriptionDietary 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 | Dietary supplement | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Herbs in people with Breast Cancer and Bone Metastasis, run by Shanghai University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.