Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .

NCT06734533 | Recruiting DMC

• 1 other identifier: ALTER-BC-005
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Objective response rate (ORR)

  through study completion, an average of 1 year

• Disease control rate (DCR)

  through study completion, an average of 1 year

• Overall survival(OS)

  through study completion, an average of 5 year

• Incidence of Treatment-Emergent Adverse Events (Safety)

  through study completion, an average of 1 year

Interventions

Anlotinib+eribulin/nab-paclitaxel/etoposide/capecitabine/pembrolizumab/ sintilimab/ fulvestrant, etc OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HR+ metastatic breast cancer previously treated with CDK4/6is

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Interventions

sintilimab; Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Quchang Ouyang

CONTACT

15676789890; tgzybc@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: December 16, 2024
• Study Start: December 5, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CN (1)