Advanced Breast CancerNCT07888556
Exploring Curative Model for Advanced Breast Cancer: a Single-center, Prospective Phase II Clinical Study
An observational study of Advanced Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
To explore the duration of continued treatment for patients with advanced breast cancer who achieve complete response assessed by PET-CT after receiving systemic anti-tumor therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Advanced Breast Cancer
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Oct 2031
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced breast cancer who achieved complete response (CR) assessed by PET-CT after receiving systematic anti-tumor therapy.
Who may be able to join
- Histologically confirmed advanced breast cancer, including inoperable locally advanced breast cancer and recurrent/metastatic breast cancer.
- No restriction on ER, PR and HER2 status.
- Prior receipt of systemic anti-tumor therapy for advanced breast cancer.
- Complete response (CR) assessed by PET-CT.
- Patients voluntarily participate in this project and sign the informed consent form.
Who cannot join
- Pregnant or lactating women.
- Presence of concomitant diseases that, in the investigator's judgment, may seriously endanger patient safety or interfere with study completion.
- Patients with brain metastases.
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
Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan
Min Yan, Doctor, +8615713857388, ym200678@126.com
About this study
To explore the duration of continued treatment for patients with advanced breast cancer who achieve complete response assessed by PET-CT after receiving systemic anti-tumor therapy.
- Conditions
- Advanced Breast Cancer
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 |
|---|---|---|
| Cohort A | Continue the original anti-tumor treatment regimen for 1 year | |
| Cohort B | Continue the original anti-tumor treatment regimen for 2 years | |
| Cohort C | Continue the original anti-tumor treatment regimen for 3 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year PFS rate after treatment discontinuation
3-year progression-free survival (PFS) rate after treatment discontinuation. PFS was defined as the time from treatment discontinuation to first documented disease progression (PD) or death from any cause, whichever occurred first.
Measured: 3 years after treatment discontinuation
Secondary outcomes (4)
1-year PFS rate after treatment discontinuation
1-year progression-free survival (PFS) rate after treatment discontinuation. PFS was defined as the time from treatment discontinuation to first documented disease progression (PD) or death from any cause, whichever occurred first.
Measured: 1 year after treatment discontinuation
5-year PFS rate after treatment discontinuation
5-year progression-free survival (PFS) rate after treatment discontinuation. PFS was defined as the time from treatment discontinuation to first documented disease progression (PD) or death from any cause, whichever occurred first.
Measured: 5 years after treatment discontinuation
OS
OS was defined as the time from initiation of best treatment to death for any cause; participants without death will be censored at the date of last follow-up.
Measured: up to 5 years
QOL
Quality of Life (QOL) was defined as a comprehensive multi-dimensional index reflecting physical, psychological, social and environmental status. The FACT-B and GAD-7 scales will be used to assess patients' quality of life and influencing factors.
Measured: up to 5 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 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888556
- Sponsor's protocol ID
- HNCH-MBC22
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Curative Model for Advanced Breast Cancer: a Single-center, Prospective Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07888556
- Acronym / sponsor ID
- HNCH-MBC22
- Conditions
- Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 22 Oct 2026 (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 explore the duration of continued treatment for patients with advanced breast cancer who achieve complete response assessed by PET-CT after receiving systemic anti-tumor therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | –Continue the original anti-tumor treatment regimen for 1 year |
| Cohort B | – | –Continue the original anti-tumor treatment regimen for 2 years |
| Cohort C | – | –Continue the original anti-tumor treatment regimen for 3 years |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced breast cancer who achieved complete response (CR) assessed by PET-CT after receiving systematic anti-tumor therapy.
Key inclusion criteria (5 listed)
- Histologically confirmed advanced breast cancer, including inoperable locally advanced breast cancer and recurrent/metastatic breast cancer.
- No restriction on ER, PR and HER2 status.
- Prior receipt of systemic anti-tumor therapy for advanced breast cancer.
- Complete response (CR) assessed by PET-CT.
- Patients voluntarily participate in this project and sign the informed consent form.
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Presence of concomitant diseases that, in the investigator's judgment, may seriously endanger patient safety or interfere with study completion.
- Patients with brain metastases.
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
3-year PFS rate after treatment discontinuation
Time frame: 3 years after treatment discontinuation
3-year progression-free survival (PFS) rate after treatment discontinuation. PFS was defined as the time from treatment discontinuation to first documented disease progression (PD) or death from any cause, whichever occurred first.
4 secondary outcomes
1-year PFS rate after treatment discontinuation
Time frame: 1 year after treatment discontinuation
5-year PFS rate after treatment discontinuation
Time frame: 5 years after treatment discontinuation
OS
Time frame: up to 5 years
QOL
Time frame: up to 5 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 22 Oct 2026.
- 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.
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 Advanced Breast Cancer, run by Henan Cancer Hospital 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Oct 2026. 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?
Contact Min Yan (+8615713857388, ym200678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year PFS rate after treatment discontinuation (time frame: 3 years after treatment discontinuation). 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 22 Oct 2026.