Breast Neoplasm FemalePhase 2NCT05075512
The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer
A Phase 2 study testing anlotinib, fulvestrant in people with Breast Neoplasm Female, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- anlotinib, fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Aug 2026
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older female；
- ECOG score 0-1;
- Life expectancy is not less than 12 weeks;
- Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer;
- Premenopausal women have taken effective ovarian function suppression methods, such as drug suppression or ovariectomy;
- At least one objectively measurable breast cancer lesions according to RECIST 1.1 ;
Show all 10Show fewer
- No more than one systemic chemotherapy for metastatic disease;
- Disease relapse within 12 months after at least 24 months endocrine adjuvant therapy, or disease progress after at least 6 months endocrine salvage therapy;
- Normal function of main organs and bone marrow: Hemoglobin≥90g/L; Neutrophil count (ANC)≥1.5×109/L; Platelet count (PLT)≥80×109/L; Total bilirubin≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (≤5×ULN if has liver metastasis); Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60mL/min (Cockcroft-Gault formula);
- Sign the informed consent;
Who cannot join
- Have received prior fulvestrant or anti-angiogenic drug treatment, or known to be allergic to any excipients in the study;
- Visceral crisis;
- Uncontrolled or high-burden CNS metastases;
- Unable to swallow;
- Abnormal coagulation function;
- Tumor has invaded important blood vessels and may cause fatal bleeding;
Show all 17Show fewer
- Pleural effusion or pericardial effusion that requiring repeated drainage;
- Hypertension that cannot be well controlled by a single antihypertensive drug;
- Unstable angina, myocardial infarction within 6 months, serious arrhythmias;
- The history of immunodeficiency, including HIV or other obtained or congenital immunodeficiency diseases, or a history of organ transplantation;
- Poorly controlled diabetes;
- Abnormal urine protein, and the 24-hour quantification suggests urine protein ≥1.0g;
- Bleeding constitution or medical history
- Unhealed wounds, ulcers or fractures;
- Have arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- In other clinical trials of anti-tumor drugs simultaneously;
- Other concomitant disease or disability that endangers safety according to the judgment of investigator;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Xiaojia Wang, +86 13906500190, wxiaojia0803@163.com
About this study
Official title: A Prospective Study on Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With HR-positive and HER2-negative, Secondary Endocrine-resistant, Locally Advanced or Metastatic Breast Cancer
The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.
Read the detailed description
This study is a prospective, single-arm, open-label, phase II clinical trial. The secondary endocrine-resistant is defined as disease relapse within 12 months after at least 24 months endocrine adjuvant therapy, or disease progress after at least 6 months endocrine salvage therapy. Eligible patients were treated with oral anlotinib plus intramuscular fulvestrant till disease progression or intolerant toxicity. In the part of statistical analysis, 40 patients are required to have a 80% power to detect significant improvement in median progression-free survival from 5.8 (fulvestrant alone) to 10 (fulvestrant combined with anlotinib) months, if tested at a two-sided significance level of α=0.05.
- Conditions
- Breast Neoplasm Female
- Being tested
- anlotinib, fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anlotinib, fulvestrantDrug
Also called AL3818
anlotinib: 12 mg once daily on days 1-14, repeated every 21 days; fulvestrant: 500 mg on days 1 and 15 of cycle one, and then on day one of each subsequent 28 days cycle
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | anlotinib combined with fulvestrant Receives: Drug: anlotinib, fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Time from randomisation to tumour progression (in any way) or death (from any cause)
Measured: From randomisation to progression or death, assessed up to 60 months
Secondary outcomes (4)
Overall Response Rate
Confirmed complete response or partial response according to RECIST 1.1
Measured: From randomisation to the first occurrence of the confirmed complete response or partial response, assessed up to 24 months
Clinical Benefit Rate
Confirmed complete response or partial response or stable disease of 24 weeks' duration or longer
Measured: From randomisation to the first occurrence of the confirmed complete response or partial response or stable disease, assessed up to 24 months
Overall Survival
Time from randomisation to death (from any cause)
Measured: From randomisation to death, assessed up to 96 months
Adverse events
Adverse events occurred from randomisation to 30 days after the last dose administrated
Measured: From randomisation to 30 days after the last dose administrated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Huang, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075512
- Sponsor's protocol ID
- 2021SQGH00743
- Status last verified
- Oct 2021
- First submitted
- 9 Aug 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be shared from the trial begin and for 10 years
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With HR-positive and HER2-negative, Secondary Endocrine-resistant, Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05075512
- Acronym / sponsor ID
- 2021SQGH00743
- Conditions
- Breast Neoplasm Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Oct 2021 (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.
The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.
Detailed description
This study is a prospective, single-arm, open-label, phase II clinical trial. The secondary endocrine-resistant is defined as disease relapse within 12 months after at least 24 months endocrine adjuvant therapy, or disease progress after at least 6 months endocrine salvage therapy. Eligible patients were treated with oral anlotinib plus intramuscular fulvestrant till disease progression or intolerant toxicity. In the part of statistical analysis, 40 patients are required to have a 80% power to detect significant improvement in median progression-free survival from 5.8 (fulvestrant alone) to 10 (fulvestrant combined with anlotinib) months, if tested at a two-sided significance level of α=0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: anlotinib, fulvestrantanlotinib combined with fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years or older female；
- ECOG score 0-1;
- Life expectancy is not less than 12 weeks;
- Histology confirmed HR-positive and HER2-negative locally advanced or metastatic breast cancer;
- Premenopausal women have taken effective ovarian function suppression methods, such as drug suppression or ovariectomy;
Key exclusion criteria (17 listed)
- Have received prior fulvestrant or anti-angiogenic drug treatment, or known to be allergic to any excipients in the study;
- Visceral crisis;
- Uncontrolled or high-burden CNS metastases;
- Unable to swallow;
- Abnormal coagulation function;
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, fulvestrantAlso: AL3818anlotinib: 12 mg once daily on days 1-14, repeated every 21 days; fulvestrant: 500 mg on days 1 and 15 of cycle one, and then on day one of each subsequent 28 days cycle | Drug | experimental group |
Primary outcome
Progression-Free Survival
Time frame: From randomisation to progression or death, assessed up to 60 months
Time from randomisation to tumour progression (in any way) or death (from any cause)
4 secondary outcomes
Overall Response Rate
Time frame: From randomisation to the first occurrence of the confirmed complete response or partial response, assessed up to 24 months
Clinical Benefit Rate
Time frame: From randomisation to the first occurrence of the confirmed complete response or partial response or stable disease, assessed up to 24 months
Overall Survival
Time frame: From randomisation to death, assessed up to 96 months
Adverse events
Time frame: From randomisation to 30 days after the last dose administrated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: Yes. the data will be shared from the trial begin and for 10 years
Related trials for Breast Neoplasm Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
Jian Huang study director
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anlotinib, fulvestrant in people with Breast Neoplasm Female, run by Zhejiang 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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 12 Oct 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojia Wang (+86 13906500190, wxiaojia0803@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 (time frame: From randomisation to progression or death, assessed up to 60 months). 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 12 Oct 2021.