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

HER2-negative Breast Cancer Clinical Trial

— ALOT-BC1  

Official title:

Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer Previously Treated With Anthracyclines and Taxanes: A Multicenter, Prospective, Observational Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05334147
• Other study ID #: 2021-SR-592
• Status: Not yet recruiting
• Start date: April 15, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Wei Li
• Phone: 0086-13851603656
• Email: real.lw[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 315
• Est. completion date: September 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-negative Breast Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

References & Publications (5)

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. Review. — View Citation

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. Review. — View Citation

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 — View Citation

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. — View Citation

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. Review. Erratum in: JAMA. 2011 Jun 8;305(22):2294. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause	up to 1 year after the last patient enrolled
Secondary	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)	up to 1 year after the last patient enrolled
Secondary	Clinical benefit rate(CBR)	Proportion of patients with a complete response (CR), partial response (PR), and stable disease (SD) =24 weeks in the best objective tumor response	up to 1 year after the last patient enrolled
Secondary	overall survival(OS)	The time from the patient's initiation of treatment to death from any cause	up to 1 year after the last patient enrolled
Secondary	Incidence and Severity of adverse events	AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).	up to 1 year after the last patient enrolled