Breast CancerPhase 2COATNCT02455154
Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy
A Phase 2 study testing Letrozole, Zhongyaofufang and Xianlinggubao in people with Breast Cancer and Osteoporosis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Osteoporosis
- What is being tested?
- Letrozole, Zhongyaofufang and Xianlinggubao
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Sep 2019
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast cancer;
- Post-surgery, primary lesion been removed;
- Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
- Histologically confirmed ER and/or PR positive ;
- Receiving adjuvant AIs therapy in the following one years;
- Leukocyte ≥ 3*10(9)/L; Platelets ≥ 75*10(9)/L;
Show all 9Show fewer
- Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal range;
- Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
- Written informed consent according to the local ethics committee equirements;
Who cannot join
- Metastatic Breast Cancer;
- Received Neo-Adjuvant Endocrine Therapy;
- History of pelvic fracture or bone metabolic disease;
- Received drugs interfering bone metabolism in the last 12 months;
- Baseline Bone Mineral Density: T < -2SD;
- With other primary malignant disease;
- With severe non-malignant co-morbidity that will influence long-term follow up;
- Known severe hypersensitivity to any drugs in this study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy
To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.
Read the detailed description
Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.
- Conditions
- Breast Cancer, Osteoporosis
- Being tested
- Letrozole, Zhongyaofufang, Xianlinggubao
- Keywords
- Chinese Traditional Medicine, Osteoporosis, adjuvant endocrine therapy, early breast cancer
- Medical subject headings
- Breast Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called L
Letrozole endocrine therapy for 2.5mg qd po.
ZhongyaofufangDrug
Also called Z
Traditional Chinese Medicine for patients with Osteoporosis
XianlinggubaoDrug
Also called X
Traditional Chinese Medicine for patients with Osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| Letrozole | Placebo comparator | Early Breast Cancer patients receiving adjuvant endocrine therapy
Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Receives: Drug: Letrozole |
| Letrozole + Xinglinggubao | Active comparator | Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao
Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
Xinglinggubao: 0.5g bid po Receives: Drug: Letrozole; Drug: Xianlinggubao |
| Letrozole + Zhongyaofufang | Active comparator | Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine)
Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
Zhongyaofufang: qow po Receives: Drug: Letrozole; Drug: Zhongyaofufang |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Bone Mineral Density
The change of bone mineral density of the L2-L4 region of the spine and hip between pre- and post-endocrine therapy for one year
Measured: 1 year
Secondary outcomes (3)
Bone Frature Rate
the rate of bone fracture in patient receiving endocrine therapy
Measured: 1 year
Bone Metabolism
The change of bone metabolism assessed by the scale of serum bone alkaline phosphatase, serum C-telopeptide and urineN-telopeptide between pre- and post-endocrine therapy for one year
Measured: 1 year
Disease Free Survival
the rate of patients without disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2019
- Study completionSep 2019
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.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
- Investigators
- Kunwei Shen, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455154
- Sponsor's protocol ID
- RJBC1502
- Acronym
- COAT
- Status last verified
- Apr 2020
- First submitted
- 14 May 2015
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy
- ClinicalTrials.gov ID
- NCT02455154
- Acronym / sponsor ID
- COAT / RJBC1502
- Conditions
- Breast Cancer, Osteoporosis
- Keywords
- Chinese Traditional Medicine, Osteoporosis, adjuvant endocrine therapy, early breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 27 May 2015 (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.
To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.
Detailed description
Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Letrozole | Placebo comparator | Drug: LetrozoleEarly Breast Cancer patients receiving adjuvant endocrine therapy Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. |
| Letrozole + Xinglinggubao | Active comparator | Drug: Letrozole, Drug: XianlinggubaoEarly Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Xinglinggubao: 0.5g bid po |
| Letrozole + Zhongyaofufang | Active comparator | Drug: Letrozole, Drug: ZhongyaofufangEarly Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine) Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Zhongyaofufang: qow po |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed invasive breast cancer;
- Post-surgery, primary lesion been removed;
- Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
- Histologically confirmed ER and/or PR positive ;
- Receiving adjuvant AIs therapy in the following one years;
Key exclusion criteria (8 listed)
- Metastatic Breast Cancer;
- Received Neo-Adjuvant Endocrine Therapy;
- History of pelvic fracture or bone metabolic disease;
- Received drugs interfering bone metabolism in the last 12 months;
- Baseline Bone Mineral Density: T < -2SD;
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 |
|---|---|---|
| LetrozoleAlso: LLetrozole endocrine therapy for 2.5mg qd po. | Drug | Letrozole, Letrozole + Xinglinggubao, Letrozole + Zhongyaofufang |
| ZhongyaofufangAlso: ZTraditional Chinese Medicine for patients with Osteoporosis | Drug | Letrozole + Zhongyaofufang |
| XianlinggubaoAlso: XTraditional Chinese Medicine for patients with Osteoporosis | Drug | Letrozole + Xinglinggubao |
Primary outcome
Change of Bone Mineral Density
Time frame: 1 year
The change of bone mineral density of the L2-L4 region of the spine and hip between pre- and post-endocrine therapy for one year
3 secondary outcomes
Bone Frature Rate
Time frame: 1 year
Bone Metabolism
Time frame: 1 year
Disease Free Survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Kunwei Shen, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole, Zhongyaofufang and Xianlinggubao in people with Breast Cancer and Osteoporosis, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Change of Bone Mineral Density (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 14 Apr 2020.