HR+ Breast CancerNCT06734533
Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .
An observational study of HR+ Breast Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative 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
- HR+ Breast Cancer
- What is being tested?
- Anlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etc
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2024to 30 Dec 2025
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HR+ metastatic breast cancer previously treated with CDK4/6is
Who may be able to join
- Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;
- Presence of measurable lesions as defined by RECIST 1.1 criteria;
- Histopathologically confirmed HR-positive/HER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0/1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;
- Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;
- Prior treatment with at least one line of CDK4/6 inhibitors and endocrine therapy;
- Disease progression following aromatase inhibitor (AI) or fulvestrant combined with CDK4/6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease.
Who cannot join
- Patients with HER2-positive breast cancer confirmed by histology or cytology;
- Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;
- Detection of a second primary malignant tumor at the time of enrollment;
- Failure to complete CDK4/6 inhibitor therapy;
- Pregnant or breastfeeding patients;
- Presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods;
- Patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab;
- Patients currently receiving any other anti-tumor treatment for any other malignancies.
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, 1 recruiting
- Recruiting
Hunan Provincial Tumor Hospital
Changsha, Hunan
Li, 15616453102, tgzybc@163.com
About this study
Official title: A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is.
Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.
- Conditions
- HR+ Breast Cancer
- Being tested
- Anlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etcOther
Anlotinib (8/10/12 mg daily, Day 1-14 of each cycle) was administered orally to fasting patients, with dose reductions to 10 mg or 8 mg in cases of intolerable toxicity. Combination agents included eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant, among others.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Objective response rate (ORR)
The ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
Measured: through study completion, an average of 1 year
Disease control rate (DCR)
The DCR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) or partial response (PR) or stable disease (SD).
Measured: through study completion, an average of 1 year
Overall survival(OS)
OS, defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Measured: through study completion, an average of 5 year
Incidence of Treatment-Emergent Adverse Events (Safety)
All the treatment-related adverse events occurred as assessed by CTCAE v4.0
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start5 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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 HR+ 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734533
- Sponsor's protocol ID
- ALTER-BC-005
- Status last verified
- Dec 2024
- First submitted
- 3 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen Y, Liu B, Chen Z, Huang P, Wu X, Zhang Y, Sun T, Dong F, Wu T, Zong H, Gan L, Shao B, Ouyang Q. Anlotinib-containing regimens in HR+ advanced breast cancer after prior CDK4/6 inhibitor progression. NPJ Breast Cancer. 2026 Jun 24. doi: 10.1038/s41523-026-00982-5. Online ahead of print.
PubMed 42342669
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Option for Post-CDK4/6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4/6is.
- ClinicalTrials.gov ID
- NCT06734533
- Acronym / sponsor ID
- ALTER-BC-005
- Conditions
- HR+ Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 5 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Dec 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.
Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4/6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4/6 inhibitor.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HR+ metastatic breast cancer previously treated with CDK4/6is
Key inclusion criteria (6 listed)
- Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;
- Presence of measurable lesions as defined by RECIST 1.1 criteria;
- Histopathologically confirmed HR-positive/HER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0/1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;
- Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;
- Prior treatment with at least one line of CDK4/6 inhibitors and endocrine therapy;
Key exclusion criteria (8 listed)
- Patients with HER2-positive breast cancer confirmed by histology or cytology;
- Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;
- Detection of a second primary malignant tumor at the time of enrollment;
- Failure to complete CDK4/6 inhibitor therapy;
- Pregnant or breastfeeding patients;
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 |
|---|---|---|
| Anlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etcAnlotinib (8/10/12 mg daily, Day 1-14 of each cycle) was administered orally to fasting patients, with dose reductions to 10 mg or 8 mg in cases of intolerable toxicity. Combination agents included eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant, among others. | Other | – |
Primary outcome
Progression free survival (PFS)
Time frame: through study completion, an average of 1 year
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
4 secondary outcomes
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
Disease control rate (DCR)
Time frame: through study completion, an average of 1 year
Overall survival(OS)
Time frame: through study completion, an average of 5 year
Incidence of Treatment-Emergent Adverse Events (Safety)
Time frame: through study completion, an average of 1 year
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 16 Dec 2024.
- Derived from this study: PubMed 42342669Chen Y, Liu B, Chen Z, Huang P, Wu X, Zhang Y, Sun T, Dong F, Wu T, Zong H, Gan L, Shao B, Ouyang Q. Anlotinib-containing regimens in HR+ advanced breast cancer after prior CDK4/6 inhibitor progression. NPJ Breast Cancer. 2026 Jun 24. doi: 10.1038/s41523-026-00982-5. Online ahead of print.
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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 HR+ Breast Cancer, run by Hunan 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 Dec 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?
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 Quchang Ouyang (15676789890, tgzybc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: through study completion, an average of 1 year). 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 NCT06734533, 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 16 Dec 2024.