Metastatic Breast CancerNCT04258163
Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy
An observational study of Metastatic Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.
Trial summary
To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Capecitabine, Liposomal doxorubicin and Gemcitabine
- Type of treatment
- Injection or infusion
- How many people
- 760 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2019to 1 Jul 2019
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This is a multi-center real world study to compare maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and observation in patients with HR-positive MBC who achieved disease control after first-line chemotherapy. Patients were retrospectively enrolled from 3 different medical center.
Who may be able to join
- Patients with pathologically clear invasive breast cancer between 2003 and 2018;
- Female,18-75 years old;
- Measurable metastatic lesion according to RECIST 1.1 evaluation criteria;
- The first-line chemotherapy regimen is a breast cancer combination or single-agent chemotherapy regimen recommended by the NCCN guidelines;
- First-line chemotherapy is effective (according to RECIST1.1 evaluation criteria, the efficacy is evaluated as complete response (CR), partial response (PR), or steady state (SD));
- After the last cycle of first-line chemotherapy, patients should still be in a state of no progress for at least 4 weeks;
- Patients' Karnofsky performance status (KPS) scores were ≥70.
Who cannot join
- Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.
Trial locations and contacts
3 sites in 1 country.
China3 sites
First People's Hospital of Foshan
Foshan, Guangdong
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510000
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
About this study
To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).
Read the detailed description
There are several options for MBC patients who are responding to chemotherapy, to continue treatment with a fix number of cycles or until disease progression which also known as maintenance chemotherapy (MCT), to stop chemotherapy and take a watch and wait strategy, or to stop chemotherapy and start the maintenance endocrine therapy (MET) for hormone receptor (HR) positive patients. Since the role of maintenance therapy in prolonging the overall survival (OS) and progression-free survival (PFS) of MBC was controversial in previous studies, the investigators performed a systematic review of randomized controlled trials to detect the association of survival with maintenance therapy in patients with MBC after first-line chemotherapy. And the investigators further performed a multi-center retrospective real-world study to evaluate these two maintenance modalities.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Capecitabine, Liposomal doxorubicin, Gemcitabine, Fulvestrant, Anastrozole
- Keywords
- Metastatic Breast Cancer, Maintenance Chemotherapy, Maintenance Endocrine Therapy, Overall Survival, Safety
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Maintenance Chemotherapy
1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days
Liposomal doxorubicinDrug
Also called Maintenance Chemotherapy
50 mg/m 2 IV day 1, cycled every 28 days
GemcitabineDrug
Also called Maintenance Chemotherapy
800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days
FulvestrantDrug
Also called Maintenance Endocrine Therapy
500mg IH Days 0, 14, 28, then every 28 days
AnastrozoleDrug
Also called Maintenance Endocrine Therapy
1mg PO qd
LetrozoleDrug
Also called Maintenance Endocrine Therapy
2.5mg PO qd
| Study group | Role | What they receive |
|---|---|---|
| MCT Group | People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy. Receives: Drug: Capecitabine; Drug: Liposomal doxorubicin; Drug: Gemcitabine | |
| MET Group | People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy. Receives: Drug: Fulvestrant; Drug: Anastrozole; Drug: Letrozole | |
| Observation Group | People who didn't receive any maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
From enrollment to death (for any reason)
Measured: Estimated 36 months
Secondary outcomes (1)
Progression free survival (PFS)
From enrollment to progression or death (for any reason)
Measured: Estimated 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
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 Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, First People's Hospital of Foshan
- Responsible party
- Principal investigator, Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Herui Yao, PhD, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258163
- Sponsor's protocol ID
- SYSEC-KY-KS-2019-099
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ren W, Yu Y, Hong H, Wang Y, Gao Q, Chen Y, Chen P, Zhao J, Ou Q, Lin D, Fu T, Tan Y, Li C, Xie X, Ye G, Tang J, Yao H. Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study. Cancer Res Treat. 2022 Oct;54(4):1038-1052. doi: 10.4143/crt.2021.698. Epub 2022 Feb 4.
PubMed 35130417
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT04258163
- Acronym / sponsor ID
- SYSEC-KY-KS-2019-099
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Maintenance Chemotherapy, Maintenance Endocrine Therapy, Overall Survival, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, First People's Hospital of Foshan
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 6 Feb 2020 (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.
To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).
Detailed description
There are several options for MBC patients who are responding to chemotherapy, to continue treatment with a fix number of cycles or until disease progression which also known as maintenance chemotherapy (MCT), to stop chemotherapy and take a watch and wait strategy, or to stop chemotherapy and start the maintenance endocrine therapy (MET) for hormone receptor (HR) positive patients. Since the role of maintenance therapy in prolonging the overall survival (OS) and progression-free survival (PFS) of MBC was controversial in previous studies, the investigators performed a systematic review of randomized controlled trials to detect the association of survival with maintenance therapy in patients with MBC after first-line chemotherapy. And the investigators further performed a multi-center retrospective real-world study to evaluate these two maintenance modalities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MCT Group | – | Drug: Capecitabine, Drug: Liposomal doxorubicin, Drug: GemcitabinePeople who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy. |
| MET Group | – | Drug: Fulvestrant, Drug: Anastrozole, Drug: LetrozolePeople who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy. |
| Observation Group | – | –People who didn't receive any maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a multi-center real world study to compare maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and observation in patients with HR-positive MBC who achieved disease control after first-line chemotherapy. Patients were retrospectively enrolled from 3 different medical center.
Key inclusion criteria (7 listed)
- Patients with pathologically clear invasive breast cancer between 2003 and 2018;
- Female,18-75 years old;
- Measurable metastatic lesion according to RECIST 1.1 evaluation criteria;
- The first-line chemotherapy regimen is a breast cancer combination or single-agent chemotherapy regimen recommended by the NCCN guidelines;
- First-line chemotherapy is effective (according to RECIST1.1 evaluation criteria, the efficacy is evaluated as complete response (CR), partial response (PR), or steady state (SD));
Key exclusion criteria (1 listed)
- Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.
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 |
|---|---|---|
| CapecitabineAlso: Maintenance Chemotherapy1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days | Drug | MCT Group |
| Liposomal doxorubicinAlso: Maintenance Chemotherapy50 mg/m 2 IV day 1, cycled every 28 days | Drug | MCT Group |
| GemcitabineAlso: Maintenance Chemotherapy800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days | Drug | MCT Group |
| FulvestrantAlso: Maintenance Endocrine Therapy500mg IH Days 0, 14, 28, then every 28 days | Drug | MET Group |
| AnastrozoleAlso: Maintenance Endocrine Therapy1mg PO qd | Drug | MET Group |
| LetrozoleAlso: Maintenance Endocrine Therapy2.5mg PO qd | Drug | MET Group |
Primary outcome
Overall Survival (OS)
Time frame: Estimated 36 months
From enrollment to death (for any reason)
1 secondary outcome
Progression free survival (PFS)
Time frame: Estimated 18 months
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 10 Feb 2020.
- Derived from this study: PubMed 35130417Ren W, Yu Y, Hong H, Wang Y, Gao Q, Chen Y, Chen P, Zhao J, Ou Q, Lin D, Fu T, Tan Y, Li C, Xie X, Ye G, Tang J, Yao H. Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study. Cancer Res Treat. 2022 Oct;54(4):1038-1052. doi: 10.4143/crt.2021.698. Epub 2022 Feb 4.
- 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. This study is not recruiting at the moment.
Herui Yao, PhD study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites 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 1 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Overall Survival (OS) (time frame: Estimated 36 months). 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 NCT04258163, 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 10 Feb 2020.