Breast NeoplasmsNCT02583828
Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
A study testing Cyclophosphamide 50mg and Letrozole 2.5 mg in people with Breast Neoplasms and Neoplasm Metastasis, run by Capital Medical University at 1 site in China.
Trial summary
This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- Cyclophosphamide 50mg and Letrozole 2.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2021
- Phase
- Interventional
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive;
- Elderly women (age ≥ 65years)
- Failure or relapse from standard chemotherapy or unfit for chemotherapy
- Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Adequate bone marrow, liver and renal function;
- Estimated life expectancy of at least 3 months.
Who cannot join
- Serious or uncontrolled concurrent medical illness
- Uncontrolled primary and metastatic brain tumor
- History of second primary malignancies
- Having been enrolled in other clinical trials within a month
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical Unvierstiy Cancer Center/ Beijing Shijitan Hospital
Beijing, 100038
About this study
This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- Cyclophosphamide 50mg, Letrozole 2.5 mg
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide 50mgDrug
Letrozole 2.5 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide alone | Active comparator | Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in this arm will receive cyclophosphamide 50 mg daily. Receives: Drug: Cyclophosphamide 50mg |
| Cyclophosphamide plus letrozole for resistant patients | Experimental | Patients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily. Receives: Drug: Cyclophosphamide 50mg; Drug: Letrozole 2.5 mg |
| Cyclophosphamide plus letrozole for treat-naive patients | Experimental | Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily. Receives: Drug: Cyclophosphamide 50mg; Drug: Letrozole 2.5 mg |
| letrozole alone | Active comparator | Patients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive letrozole 2.5 mg daily. Receives: Drug: Letrozole 2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival(PFS) of the subjects
Time from the randomization date to the start of disease progression or subject death from any cause (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1for elderly metastatic breast cancer subjects).
Measured: up to approximately 2 years
Secondary outcomes (3)
Safety of each treatment regimen for the subjects
Assessment based on Adverse Events (AEs) , Serious Adverse Events (SAEs), laboratory abnormalities in subjects .
Measured: up to approximately 2 years
Evaluate the quality of life for the subjects in the each treatment regimen
Subjects complete questionnaire in every 8 weeks.
Measured: up to approximately 2 years
Compare disease control rate for the subjects
Complete response (CR), Partial response (PR), and Stable Disease (SD) more than or equal to 8 weeks.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2020
- Study completionDec 2021
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 Capital Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ren MD, PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583828
- Sponsor's protocol ID
- LET+CTX
- Status last verified
- Feb 2024
- First submitted
- 13 Oct 2015
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02583828
- Acronym / sponsor ID
- LET+CTX
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 22 Oct 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.
This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide alone | Active comparator | Drug: Cyclophosphamide 50mgPatients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in this arm will receive cyclophosphamide 50 mg daily. |
| Cyclophosphamide plus letrozole for resistant patients | Experimental | Drug: Cyclophosphamide 50mg, Drug: Letrozole 2.5 mgPatients who were resistant to letrozole will be randomized to receive cyclophosphamide alone or letrozole plus cyclophosphamide. Patients in the this will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily. |
| Cyclophosphamide plus letrozole for treat-naive patients | Experimental | Drug: Cyclophosphamide 50mg, Drug: Letrozole 2.5 mgPatients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive cyclophosphamide 50 mg daily plus letrozole 2.5 mg daily. |
| letrozole alone | Active comparator | Drug: Letrozole 2.5 mgPatients who haven't received letrozole hormonotherapy will be randomized to receive letrozole plus cyclophosphamide or letrozole alone. Patients in this arm will receive letrozole 2.5 mg daily. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive;
- Elderly women (age ≥ 65years)
- Failure or relapse from standard chemotherapy or unfit for chemotherapy
- Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Key exclusion criteria (4 listed)
- Serious or uncontrolled concurrent medical illness
- Uncontrolled primary and metastatic brain tumor
- History of second primary malignancies
- Having been enrolled in other clinical trials within a month
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 |
|---|---|---|
| Cyclophosphamide 50mg | Drug | Cyclophosphamide alone, Cyclophosphamide plus letrozole for resistant patients, Cyclophosphamide plus letrozole for treat-naive patients |
| Letrozole 2.5 mg | Drug | Cyclophosphamide plus letrozole for resistant patients, Cyclophosphamide plus letrozole for treat-naive patients, letrozole alone |
Primary outcome
Progression free survival(PFS) of the subjects
Time frame: up to approximately 2 years
Time from the randomization date to the start of disease progression or subject death from any cause (progression assessed by investigator using Response Evaluation Criteria in Solid Tumors 1.1for elderly metastatic breast cancer subjects).
3 secondary outcomes
Safety of each treatment regimen for the subjects
Time frame: up to approximately 2 years
Evaluate the quality of life for the subjects in the each treatment regimen
Time frame: up to approximately 2 years
Compare disease control rate for the subjects
Time frame: up to approximately 2 years
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 7 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophosphamide 50mg and Letrozole 2.5 mg in people with Breast Neoplasms and Neoplasm Metastasis, run by Capital Medical University 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 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: finished, as of the sponsor's last update on 7 Feb 2024. 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?
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?
Progression free survival(PFS) of the subjects (time frame: up to approximately 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 7 Feb 2024.