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Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

paclitaxel

cisplatin

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring apatinib, neoadjuvant therapy, breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

breast invasive carcinoma diagnosed by core needle biopsy, without previous treatments for breast cancer;
with the molecular subtypes of triple-negative, HER2+ or Luminal B, confirmed by immunohistochemistry;
breast cancer within stage IIb-IIIc, planned to receive neoadjuvant therapy;
women aged from 18 to 70 years old;
required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
left ventricular ejection fraction (LVEF) greater than 55% without clinical symptoms or signs of heart failure;
Adequate bone marrow, with white blood cell ≥4.0×109 /L，neutrophils ≥2.0×109 /L, platelet ≥100×109 /L, hemoglobin ≥ 90 g/L；
Serum creatinine ranges from 44 to 133 mol/L;
Glutamic pyruvic transaminase and Glutamic-oxalacetic Transaminase ≤2 times to superior limit of normal value;
bilirubin ≤ superior limit of normal value;
Expected survival ≥ 12 months;
pregnancy tests must be negative, and the couples of patients should agree to use effective contraception during treatment and the following one year;
approved by the institutional ethnics committee of the Fourth Hospital of Hebei Medical University, with signature to the Informed consent.

Exclusion Criteria:

severe systemic infection;
being allergic or intolerant to apatinib, paclitaxel, cisplatin;
having received any testing drugs, radiotherapy or other chemotherapy drugs within 30 days before being enrolled in this trial;
uncontrolled hypertension, severe heart function;
researchers believe that participating in the test does not meet the best interests of the patients (e.g. cause adverse health) or may interfere with the evaluation of response.

Sites / Locations

Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

apatinib+TP

Arm Description

TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).

TP neoadjuvant chemotherapy alone (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3).

Outcomes

Primary Outcome Measures

The primary endpoint is pathological complete remission (pCR)

pCR was defined as no histological evidence of invasive tumor cells in the surgical breast specimen and draining nodes. The presence of residual ductal carcinoma-in situ was not included in the pCR category after neoadjuvant treatment.

Secondary Outcome Measures

The second endpoint includes the objective response rate (ORR)

Evaluation of tumor response was performed by independent evaluators who were blinded to the arm assignment consisted of 2 oncologists and 2 pathologists. Tumor response status was defined according to the Response Evaluation Criteria in Solid Tumors Committee (RECIST). Specifically, the complete response (CR) was defined as the disappearance of all the lesions both in breast specimen and draining nodes; The primary endpoint ORR composed of tumor response classifications of CR and partial response (PR).

Adverse events (AE)

Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. Patients were assessed for toxicities before each administration., and toxicity was graded accordingly.

Full Information

NCT ID

NCT03580395

First Posted

May 21, 2018

Last Updated

July 6, 2021

Sponsor

Hebei Medical University Fourth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03580395

Brief Title

Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

Official Title

Efficacy and Safety of Apatinib Added to Docetaxel and Cisplatin Neoadjuvant Therapy for Patients With Breast Cancer: a Randomized, Parallel Controlled Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University Fourth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.

6. Conditions and Keywords

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

Breast Cancer

Keywords

apatinib, neoadjuvant therapy, breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

apatinib+TP

Arm Type

Experimental

Arm Description

TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).

Arm Title

Arm Type

Sham Comparator

Arm Description

TP neoadjuvant chemotherapy alone (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3).

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

500mg, day1-21,neoadjuvant therapy

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Description

paclitaxel 165mg/m2 day 1

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

cisplatin 40mg, day 1-3

Primary Outcome Measure Information:

Title

The primary endpoint is pathological complete remission (pCR)

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

The second endpoint includes the objective response rate (ORR)

Description

Time Frame

4 months

Title

Adverse events (AE)

Description

Time Frame

4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: breast invasive carcinoma diagnosed by core needle biopsy, without previous treatments for breast cancer; with the molecular subtypes of triple-negative, HER2+ or Luminal B, confirmed by immunohistochemistry; breast cancer within stage IIb-IIIc, planned to receive neoadjuvant therapy; women aged from 18 to 70 years old; required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; left ventricular ejection fraction (LVEF) greater than 55% without clinical symptoms or signs of heart failure; Adequate bone marrow, with white blood cell ≥4.0×109 /L，neutrophils ≥2.0×109 /L, platelet ≥100×109 /L, hemoglobin ≥ 90 g/L； Serum creatinine ranges from 44 to 133 mol/L; Glutamic pyruvic transaminase and Glutamic-oxalacetic Transaminase ≤2 times to superior limit of normal value; bilirubin ≤ superior limit of normal value; Expected survival ≥ 12 months; pregnancy tests must be negative, and the couples of patients should agree to use effective contraception during treatment and the following one year; approved by the institutional ethnics committee of the Fourth Hospital of Hebei Medical University, with signature to the Informed consent. Exclusion Criteria: severe systemic infection; being allergic or intolerant to apatinib, paclitaxel, cisplatin; having received any testing drugs, radiotherapy or other chemotherapy drugs within 30 days before being enrolled in this trial; uncontrolled hypertension, severe heart function; researchers believe that participating in the test does not meet the best interests of the patients (e.g. cause adverse health) or may interfere with the evaluation of response.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yunjiang Liu, MD.,PhD

Organizational Affiliation

Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050011

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

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