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Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer (ACNTBC)

Primary Purpose

Breast Cancer Stage II

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib

About this trial

This is an interventional treatment trial for Breast Cancer Stage II focused on measuring Breast cancer Antivascular drugs Neoadjuvant therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

All patients were HER2 negative, deﬁ ned as munohistochemistry of 0/1+, or if 2+, ﬂ uorescence insitu hybridisation showed no evidence of ampliﬁ cation of the HER2 gene.
Patients were required to have a palpable primary tumor at least 2.0 cm in diameter in the breast, as assessed by physical examination, and to be classified as having tumor stage T1c to T3, nodal stage N0 to N2a, and metastasis stage M0.
Other eligibility criteria adequate cardiac function (left ventricular ejection fraction within the normal institutional range, as assessed by multiplegated acquisition scan or echocardiogram), adequate bone marrow, hepatic, and renal function, and appropriate Eastern Cooperative Oncology Group (ECOG) performance status (0-2).
All patients provided written informed consent.

Exclusion Criteria:

Previously received anti-angiogenesis targeted drug therapy.
patients have previous diagnosis of ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, gastroduodenal ulcer, symptomatic diverticulitis, or inflammatory bowel disease.
Previously received chemotherapy, radiotherapy, or endocrine therapy as treatment for breast cancer was allowed.
No uncont rolled hypertension.

Sites / Locations

Xijing Hospital Affiliated to Air Force Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anlotinib

Arm Description

Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles) Combined TAC×6 cycles.

Outcomes

Primary Outcome Measures

pCR( pathological complete remission)

Pathological complete remission rate assessed by the investigator

Secondary Outcome Measures

ADR

Adverse Drug Reactions

DFS

DFS(Disease-free survival)

Full Information

NCT ID

NCT05558722

First Posted

July 19, 2022

Last Updated

September 25, 2022

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05558722

Brief Title

Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer

Acronym

ACNTBC

Official Title

Anlotinib Plus Chemotherapy as Neoadjuvant Treatment of High-risk, Early-stage Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer: A Prospective, Single-arm, Single-center, Phase II Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2022 (Anticipated)

Primary Completion Date

July 30, 2023 (Anticipated)

Study Completion Date

July 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This study aims to evaluate the efficacy and safety of adding anlotinib to standard neoadjuvant chemotherapy in primary (HER2)-negative breast cancer. Patients aged 18 years or older with previously untreated stage ⅡB-IIIA histologically documented (HER2)-negative breast cancer were assigned to receive chemotherapy plus oral Anlotinib. The primary endpoint was pathologic complete response (pCR) (no invasive carcinoma in breast or axilla). Secondary end points included safety and disease-free survival (DFS).

Detailed Description

Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This phase II study aims to evaluate the efficacy and safety of adding anlotinib to standard neoadjuvant chemotherapy in primary (HER2)-negative breast cancer. Patients aged 18 years or older with previously untreated stage ⅡB-IIIA histologically documented (HER2)-negative breast cancer were assigned to receive chemotherapy plus oral Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles). Chemotherapy comprised of pirarubicin at 50 mg/m2 and cyclophosphamide at 500 mg/m2 and albumin-bound paclitaxel at 200 mg/m2, (d1, 21 days per cycle; both total 6 cycles), which was then followed by surgery. The primary endpoint was pathologic complete response (pCR) (no invasive carcinoma in breast or axilla). Secondary end points included safety and disease-free survival (DFS). Stratification was based on the clinical breast cancer stage .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Stage II

Keywords

Breast cancer Antivascular drugs Neoadjuvant therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Assigned to receive chemotherapy plus oral Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles)，chemotherapy comprised of pirarubicin at 50 mg/m2 and cyclophosphamide at 500 mg/m2 and albumin-bound paclitaxel at 200 mg/m2, (d1, 21 days per cycle; both total 6 cycles), which was then followed by surgery.

Masking

None (Open Label)

Masking Description

Check all roles that are masked or check None.

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Anlotinib

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Anlotinib

Other Intervention Name(s)

TAC

Intervention Description

Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 5 cycles) Combined TAC×6 cycles: albumin-bound paclitaxel (200mg/m2, 1d Q3W) + pirarubicin （50mg/m2, 1d Q3W) + cyclophosphamide (500mg/m2, 1d Q3W);

Primary Outcome Measure Information:

Title

pCR( pathological complete remission)

Description

Pathological complete remission rate assessed by the investigator

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

ADR

Description

Adverse Drug Reactions

Time Frame

8 weeks

Title

DFS

Description

DFS(Disease-free survival)

Time Frame

8 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients were HER2 negative, deﬁ ned as munohistochemistry of 0/1+, or if 2+, ﬂ uorescence insitu hybridisation showed no evidence of ampliﬁ cation of the HER2 gene. Patients were required to have a palpable primary tumor at least 2.0 cm in diameter in the breast, as assessed by physical examination, and to be classified as having tumor stage T1c to T3, nodal stage N0 to N2a, and metastasis stage M0. Other eligibility criteria adequate cardiac function (left ventricular ejection fraction within the normal institutional range, as assessed by multiplegated acquisition scan or echocardiogram), adequate bone marrow, hepatic, and renal function, and appropriate Eastern Cooperative Oncology Group (ECOG) performance status (0-2). All patients provided written informed consent. Exclusion Criteria: Previously received anti-angiogenesis targeted drug therapy. patients have previous diagnosis of ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, gastroduodenal ulcer, symptomatic diverticulitis, or inflammatory bowel disease. Previously received chemotherapy, radiotherapy, or endocrine therapy as treatment for breast cancer was allowed. No uncont rolled hypertension.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ting Wang, PhD

Phone

0086-13700283101

ting_w100@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ting Wang, PhD

Organizational Affiliation

Xijing Hospital Affiliated to Air Force Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital Affiliated to Air Force Military Medical University

City

Xi'an

State/Province

Shannxi Province

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ting Wang, PhD

Phone

0086-13700283101

ting_w100@126.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer

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