Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer

NCT ID: NCT05334147

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2025-09-01

Brief Summary

The study is being conducted to evaluate the efficacy and safety of anlotinib combined with chemotherapy treatment for patients with HER2 negative advanced breast cancer previously received anthracyclines and taxanes

Detailed Description

Breast cancer is the most frequent malignancy in women worldwide. Treatments on HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients.

Anlotinib is an anti-angiogenic small-molecule butyrate kinase inhibitor, and preliminary phase II study results show that anlotinib has good efficacy and tolerability in the treatment of HER-2-negative advanced breast cancer.

This study is a prospective, multicenter, observational clinical study that will collect and report anlotinib in combination with anlotinib in patients with HER2-negative advanced breast cancer treated with anthracyclines and taxanes in a real-world clinical setting Efficacy and safety data for chemotherapy treatments.

Conditions

HER2-negative Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Anlotinib in combination with chemotherapy

anlotinib12mg qd p.o. d1-14/21day/cycle；eribulin 1.4 mg/m2，d1\&d8/21day/cycle；capecitabine 1000 mg/m2，bid，d1-14/21day/cycle.

No interventions assigned to this group

chemotherapy

eribulin 1.4 mg/m2，d1\&d8/21day/cycle；capecitabine 1000 mg/m2，bid，d1-14/21day/cycle.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old (calculated on the day of signing informed consent);

2. Histologically diagnosed advanced breast cancer, including inoperable locally advanced breast cancer or recurrent/metastatic breast cancer;

3. Immunohistochemical detection of HER-2 (-) or (1+), of which HER-2 (2+) must be tested by FISH and the result is negative;

4. All patients have previously underwent chemotherapy containing anthracyclines and taxanes (adjuvant, neoadjuvant or rescue therapy) , and treatment failure or disease progression received at most two chemotherapy regimens after recurrence/metastasis. HR+/HER2- breast cancer patients need to complete endocrine drug therapy;

5. Physical condition ECOG PS: 0-1;

6. There is at least 1 measurable lesion of metastasis according to RECIST 1.1;

7. The patients voluntarily joined the project and signed the informed consent.

Exclusion Criteria

1. Pregnant or lactating women;

2. Patients with a previous history of breast cancer were excluded, except for ipsilateral DCIS who received only local therapy ≥5 years ago; patients with a history of any other cancer (except non-melanoma skin cancer or cervical carcinoma in situ) were excluded;

3. allergic to Anlotinib;

4. Received eribulin, capecitabine treatment or anti-angiogenic drug treatment in the past;

5. Uncontrolled brain metastases (except asymptomatic, or patients with stable brain metastases receiving local treatment);

6. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongmei Yin

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Wei Li

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Wei Li

Role: CONTACT

real.lw@163.com

0086-13851603656

References

Gonzalez-Angulo AM, Morales-Vasquez F, Hortobagyi GN. Overview of resistance to systemic therapy in patients with breast cancer. Adv Exp Med Biol. 2007;608:1-22. doi: 10.1007/978-0-387-74039-3_1.

Reference Type: BACKGROUND

PMID: 17993229 (View on PubMed)

Banerjee S, Dowsett M, Ashworth A, Martin LA. Mechanisms of disease: angiogenesis and the management of breast cancer. Nat Clin Pract Oncol. 2007 Sep;4(9):536-50. doi: 10.1038/ncponc0905.

Reference Type: BACKGROUND

PMID: 17728712 (View on PubMed)

Ranpura V, Hapani S, Wu S. Treatment-related mortality with bevacizumab in cancer patients: a meta-analysis. JAMA. 2011 Feb 2;305(5):487-94. doi: 10.1001/jama.2011.51.

Reference Type: BACKGROUND

PMID: 21285426 (View on PubMed)

Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113.

Reference Type: BACKGROUND

PMID: 18160686 (View on PubMed)

Hu N, Si Y, Yue J, Sun T, Wang X, Jia Z, Gao S, Li Q, Shao Y, Wang J, Luo Y, Ma F, Xu B, Yuan P. Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer. Cancer Biol Med. 2021 Mar 12;18(3):849-59. doi: 10.20892/j.issn.2095-3941.2020.0463.

Reference Type: RESULT

PMID: 33710812 (View on PubMed)

Other Identifiers

2021-SR-592

Identifier Type: -

Identifier Source: org_study_id