Breast NeoplasmsNCT06405269
Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients
An observational study of Breast Neoplasms and Lipid Profile, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Previous studies have shown differences in the effects of different endocrine drugs on blood lipids in breast cancer, and dyslipidaemia is a major risk factor for cardiovascular disease, and it has been previously reported that the leading cause of death in postmenopausal patients with breast cancer is cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Neoplasms, Lipid Profile
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Young breast cancer patients who fulfil the following criteria: less than or equal to 40, surgically resectable, requiring (neo)adjuvant chemotherapy or endocrine therapy.
Who may be able to join
- ECOG score 0-1
- Resectable breast cancer
- No distant metastases on postoperative imaging assessment
- Patients proposed for (neo)adjuvant therapy
- No previous oral lipid-lowering drugs, serum LDL-C level within normal range, i.e. LDL-C value: \<3.4 mmol/L
- No fatty liver by liver ultrasound/CT examination
- No major organ dysfunction
Who cannot join
- Patients with pre-existing hyperlipidaemia, coronary heart disease, fatty liver disease, or who have received or are receiving lipid-lowering medication
- Enrolled in another study or less than or equal to 4 weeks since discontinuation of other medications
- Presence of severe dysfunction of vital organs
- Patients with other malignancies (except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumours that have been cured for at least 5 years)
- Acute infectious diseases or chronic infectious diseases in active stage
- History of uncontrolled epilepsy, central nervous system disease or mental disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: A Multicentre Prospective Cohort Study: Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients
Previous studies have shown differences in the effects of different endocrine drugs on blood lipids in breast cancer, and dyslipidaemia is a major risk factor for cardiovascular disease, and it has been previously reported that the leading cause of death in postmenopausal patients with breast cancer is cardiovascular disease, but the effects of endocrine drug therapy on blood lipids in young breast cancer patients (age ≤40) are not clear. Previously, our group conducted a preliminary retrospective analysis of young patients on endocrine therapy and found that dyslipidaemia was also a common adverse effect of treatment in young breast cancer patients; therefore, dyslipidaemia induced by antineoplastic therapy not only occurs in postmenopausal patients, but is also prevalent in premenopausal and even younger patients. Therefore, this study intends to evaluate the effects of different treatment regimens on lipids in early-stage young breast cancer patients and to explore the optimal timing of lipid-lowering drug interventions to provide a basis for clinical practice.
- Conditions
- Breast Neoplasms, Lipid Profile
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy group（Hormone receptor negative breast cancer） | Patients receiving adjuvant chemotherapy after surgery for hormone receptor-negative breast cancer | |
| Adjuvant chemotherapy group（Hormone receptor positive breast cancer） | Patients receiving adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer | |
| Without adjuvant chemotherapy group（Hormone receptor positive breast cancer） | Patients without adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who developed LDL-C abnormalities in 3 groups
Observe and compare differences between groups
Measured: 2 years
Secondary outcomes (2)
Proportion of patients who developed TC，LDL-C，and TG abnormalities in 3 groups
Observe and compare differences between groups
Measured: 2 years
Proportion of patients developing fatty liver in 3 groups
Observe and compare differences between groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start6 May 2024
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405269
- Sponsor's protocol ID
- NCC3872
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Cohort Study: Effect of (neo)Adjuvant Therapy on Lipids in Young Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06405269
- Acronym / sponsor ID
- NCC3872
- Conditions
- Breast Neoplasms, Lipid Profile
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 8 May 2024 (actual)
- 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.
Previous studies have shown differences in the effects of different endocrine drugs on blood lipids in breast cancer, and dyslipidaemia is a major risk factor for cardiovascular disease, and it has been previously reported that the leading cause of death in postmenopausal patients with breast cancer is cardiovascular disease, but the effects of endocrine drug therapy on blood lipids in young breast cancer patients (age ≤40) are not clear. Previously, our group conducted a preliminary retrospective analysis of young patients on endocrine therapy and found that dyslipidaemia was also a common adverse effect of treatment in young breast cancer patients; therefore, dyslipidaemia induced by antineoplastic therapy not only occurs in postmenopausal patients, but is also prevalent in premenopausal and even younger patients. Therefore, this study intends to evaluate the effects of different treatment regimens on lipids in early-stage young breast cancer patients and to explore the optimal timing of lipid-lowering drug interventions to provide a basis for clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy group（Hormone receptor negative breast cancer） | – | –Patients receiving adjuvant chemotherapy after surgery for hormone receptor-negative breast cancer |
| Adjuvant chemotherapy group（Hormone receptor positive breast cancer） | – | –Patients receiving adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer |
| Without adjuvant chemotherapy group（Hormone receptor positive breast cancer） | – | –Patients without adjuvant chemotherapy after surgery for hormone receptor-positive breast cancer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young breast cancer patients who fulfil the following criteria: less than or equal to 40, surgically resectable, requiring (neo)adjuvant chemotherapy or endocrine therapy.
Key inclusion criteria (7 listed)
- ECOG score 0-1
- Resectable breast cancer
- No distant metastases on postoperative imaging assessment
- Patients proposed for (neo)adjuvant therapy
- No previous oral lipid-lowering drugs, serum LDL-C level within normal range, i.e. LDL-C value: \<3.4 mmol/L
Key exclusion criteria (6 listed)
- Patients with pre-existing hyperlipidaemia, coronary heart disease, fatty liver disease, or who have received or are receiving lipid-lowering medication
- Enrolled in another study or less than or equal to 4 weeks since discontinuation of other medications
- Presence of severe dysfunction of vital organs
- Patients with other malignancies (except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumours that have been cured for at least 5 years)
- Acute infectious diseases or chronic infectious diseases in active stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who developed LDL-C abnormalities in 3 groups
Time frame: 2 years
Observe and compare differences between groups
2 secondary outcomes
Proportion of patients who developed TC，LDL-C，and TG abnormalities in 3 groups
Time frame: 2 years
Proportion of patients developing fatty liver in 3 groups
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoplasms and Lipid Profile, run by Cancer Institute and Hospital, 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 7 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: enrolling by invitation, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients who developed LDL-C abnormalities in 3 groups (time frame: 2 years). 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 Feb 2025.