Breast CancerNCT02765373
Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients
An observational study of Breast Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a prospective, controlled phase IV clinical trial among postmenopausal patients with hormone receptor-positive breast cancer.The main purpose is to compare the effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of breast cancer patients. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exemestane, Letrozole and Anastrozole
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jan 2020
- Phase
- Observational
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: postmenopausal women with hormone receptor-positive breast cancer who have received surgery
Who may be able to join
- Pathologic analysis verifies to be early-stage invasive breast cancer while immunohistochemistry shows estrogen receptor(ER) and/or progesterone receptor(PR) positive (ER/PR positive is defined that >1% of cells are positive).
- The patients have received surgery for breast cancer and recovered well for an interval of at least 1 week.
- The patients have received post-operational adjuvant chemotherapy and/or adjuvant radiotherapy whereas the interval of chemotherapy and/or adjuvant radiotherapy is more than 2 weeks.
- The postmenopausal women have been confirmed to be to menopausal as defined in NCCN guidelines(including post bilateral oophorectomy; age≥60 year-old; age≤60 year-old, menopause for more than 1 year and plasma Follicle-Stimulating Hormone (FSH) and estradiol levels meet the menopausal scope).
- Do not receive concomitant endocrine therapy, e.g. drug-induced menopause, tamoxifen.
- The patients do not have severe cardiopulmonary dysfunction.
Show all 13Show fewer
- ECOG score: 0-1
- The patients have enough organ function and meet the scope of aromatase inhibitors(AIs) therapy. The laboratory test indexes must comply with the following requirements:
- Blood routine: neutrophil≥1.5G/L, platelet count ≥75G/L, hemoglobin ≥100g/L Liver function: serum bilirubin ≤ 2 times the upper limit of normal value; ALT and AST≤3 times the upper limit of normal value; Renal function: serumcreatinine≤140μmol/L
- Serum low density lipoprotein-cholesterol(LDL-C) value <3.37mmol/L
- Imaging examination identifies none of local recurrence or distal metastasis.
- No other combined malignancy.
- The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
Who cannot join
- The patients are not qualified to receive the adjuvant endocrine therapy with AIs.
- The patients previously received other endocrine therapy (e.g. tamoxifen) simultaneity or the treatment with AIs (excluding those with a course of less than 3 months)
- The patients received or are receiving the lipid-lowering therapy.
- The patients suffer from other combined malignancy.
- The patients have uncontrollable mental illness.
- The patients experience severe cardiovascular diseases in the recent 6 months (e.g. unstable angina, chronic heart failure, uncontrollable hypertension >150/90 mmHg, myocardial infarction or cerebrovascular disorders).
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
This study is a prospective, controlled phase IV clinical trial among postmenopausal patients with hormone receptor-positive breast cancer.The main purpose is to compare the effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of breast cancer patients.
Read the detailed description
The study subjects are composed of postmenopausal women with hormone receptor-positive breast cancer who have received exemestane, anastrozole or letrozole followed by testing of safety variables such as low-density lipoprotein- cholesterol (LDL-C), triglyceride(TC), total cholesterol, high-density lipoprotein cholesterol(HDL), blood calcium, transaminase and fasting plasma glucose at different time intervals in two years.
- Conditions
- Breast Cancer
- Being tested
- Exemestane, Letrozole, Anastrozole
- Keywords
- aromatase inhibitors, lipid levels
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
LetrozoleDrug
AnastrozoleDrug
| Study group | Role | What they receive |
|---|---|---|
| steroidal aromatase inhibitors(AIs) | Exemestane 25mg Qd for 5 years Receives: Drug: Exemestane | |
| non-steroidal aromatase inhibitors(AIs) | Letrozole 2.5mg Qd or Anastrozole 1mg Qd for 5 years Receives: Drug: Letrozole; Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups
Measured: Change of LDL-C level from Baseline to up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Yuan, Chinese Academy of Medical Sciences
- Investigators
- Peng Yuan, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765373
- Sponsor's protocol ID
- CH-BC-030
- Status last verified
- May 2019
- First submitted
- 8 Apr 2016
- Last updated
- 13 May 2019
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Wang X, Zhu A, Wang J, Ma F, Liu J, Fan Y, Luo Y, Zhang P, Li Q, Xu B, Yuan P. Steroidal aromatase inhibitors have a more favorable effect on lipid profiles than nonsteroidal aromatase inhibitors in postmenopausal women with early breast cancer: a prospective cohort study. Ther Adv Med Oncol. 2020 May 26;12:1758835920925991. doi: 10.1177/1758835920925991. eCollection 2020.
PubMed 32518597
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02765373
- Acronym / sponsor ID
- CH-BC-030
- Conditions
- Breast Cancer
- Keywords
- aromatase inhibitors, lipid levels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2020 (estimated)
- First posted
- 6 May 2016 (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.
This study is a prospective, controlled phase IV clinical trial among postmenopausal patients with hormone receptor-positive breast cancer.The main purpose is to compare the effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of breast cancer patients.
Detailed description
The study subjects are composed of postmenopausal women with hormone receptor-positive breast cancer who have received exemestane, anastrozole or letrozole followed by testing of safety variables such as low-density lipoprotein- cholesterol (LDL-C), triglyceride(TC), total cholesterol, high-density lipoprotein cholesterol(HDL), blood calcium, transaminase and fasting plasma glucose at different time intervals in two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steroidal aromatase inhibitors(AIs) | – | Drug: ExemestaneExemestane 25mg Qd for 5 years |
| non-steroidal aromatase inhibitors(AIs) | – | Drug: Letrozole, Drug: AnastrozoleLetrozole 2.5mg Qd or Anastrozole 1mg Qd for 5 years |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- postmenopausal women with hormone receptor-positive breast cancer who have received surgery
Key inclusion criteria (13 listed)
- Pathologic analysis verifies to be early-stage invasive breast cancer while immunohistochemistry shows estrogen receptor(ER) and/or progesterone receptor(PR) positive (ER/PR positive is defined that >1% of cells are positive).
- The patients have received surgery for breast cancer and recovered well for an interval of at least 1 week.
- The patients have received post-operational adjuvant chemotherapy and/or adjuvant radiotherapy whereas the interval of chemotherapy and/or adjuvant radiotherapy is more than 2 weeks.
- The postmenopausal women have been confirmed to be to menopausal as defined in NCCN guidelines(including post bilateral oophorectomy; age≥60 year-old; age≤60 year-old, menopause for more than 1 year and plasma Follicle-Stimulating Hormone (FSH) and estradiol levels meet the menopausal scope).
- Do not receive concomitant endocrine therapy, e.g. drug-induced menopause, tamoxifen.
Key exclusion criteria (6 listed)
- The patients are not qualified to receive the adjuvant endocrine therapy with AIs.
- The patients previously received other endocrine therapy (e.g. tamoxifen) simultaneity or the treatment with AIs (excluding those with a course of less than 3 months)
- The patients received or are receiving the lipid-lowering therapy.
- The patients suffer from other combined malignancy.
- The patients have uncontrollable mental illness.
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 |
|---|---|---|
| Exemestane | Drug | steroidal aromatase inhibitors(AIs) |
| Letrozole | Drug | non-steroidal aromatase inhibitors(AIs) |
| Anastrozole | Drug | non-steroidal aromatase inhibitors(AIs) |
Primary outcome
Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups
Time frame: Change of LDL-C level from Baseline to up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Derived from this study: PubMed 32518597Wang X, Zhu A, Wang J, Ma F, Liu J, Fan Y, Luo Y, Zhang P, Li Q, Xu B, Yuan P. Steroidal aromatase inhibitors have a more favorable effect on lipid profiles than nonsteroidal aromatase inhibitors in postmenopausal women with early breast cancer: a prospective cohort study. Ther Adv Med Oncol. 2020 May 26;12:1758835920925991. doi: 10.1177/1758835920925991. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Peng Yuan principal investigator
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Chinese Academy of Medical Sciences 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 13 inclusion and 6 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 May 2019. 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. 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.
What does the primary outcome measure?
Ratio of patients whose low density lipoprotein-cholesterol（LDL-C） level ≥ 4.14 mmol/L in 2 years of administration among groups (time frame: Change of LDL-C level from Baseline to up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765373, which also lists 1 linked publication.
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 May 2019.