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Active, Not Recruiting

NCT Number: NCT03982485

Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer

RATIONALE:

The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer.

PURPOSE:

To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18~70 year-old，Female
  • Patients with histologically confirmed primary invasive breast adenocarcinoma,cT2-4N0-3M0
  • ECOG 0-1
  • HER2-negative tumor in biopsy, defined as: Immunohistochemical (IHC) 0-1+ or IHC 2+ confirmed as FISH negative.
  • Adequate organ function

Exclusion criteria

  • Unwilling to use adequate contraceptive protection during the process of the study and for at least 8 weeks after the last dose of study drug.
  • Pregnant or breastfeeding patients
  • Metastatic or recurrent patients
  • Any evidence of sense or motor nerve disorders
  • Any concurrent malignancy other than breast cancer
  • Uncontrolled hypertension with hypotensive drugs therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg). Patients with grade I or above myocardial ischemia or myocardial infarction or arrhythmia (including QT interval ≥ 440 ms) or cardiac insufficiency
  • Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
  • Coagulation disorders
  • Artery or venous thrombosis occurred within 6 months before the study begins
  • Have received prior treatment with a VEGFR TKI

Treatment and study plan

apatinib

Drug

Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week

paclitaxel

Drug

Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle

Cisplatin

Drug

Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle

Surgery

Procedure

Surgery

Primary outcomes

  1. Residual cancer burden (RCB 0-I rates）

    Time frame: Time of surgery

    RCB 0-I rates means RCB 0+I (good response) rates.

  2. Pathologic Complete Response (pCR) of the Primary Tumor in the Breast

    Time frame: Time of surgery

    Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen.

Secondary outcomes

  1. pCR in the Breast and Nodes

    Time frame: Time of surgery

    Percentage of patients absent of histologic evidence of invasive tumor cells in the surgical breast specimen and axillary lymph nodes.

  2. Near pCR in the Breast

    Time frame: Time of surgery

    Percentage of patients with the residual breast lump Less than 10%

  3. Clinical and imaging response

    Time frame: Time of surgery

    To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment

  4. Number of Participants With Drug Related Treatment Adverse Events

    Time frame: an average of 16 weeks

    Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.

  5. Neo-bioscore

    Time frame: Time of surgery

    The Neo-Bioscore staging points were determined for each patient based on information from the medical records according to the previously published work（Mittendorf EA, et al. The Neo-Bioscore Update for Staging Breast Cancer Treated With Neoadjuvant Chemotherapy: Incorporation of Prognostic Biologic Factors Into Staging After Treatment. JAMA Oncol. United States; 2016;2:929-36.）.

    Neo-Bioscore = Clinical stages score + Pathological stages score + Tumor marker score Clinical stage I =0, Clinical stage IIA =0, Clinical stage IIB =1, Clinical stage IIIA =1, Clinical stage IIIB =2, Clinical stage IIIC =2, Pathological stage 0 =0, Pathological stage I =0, Pathological stage IIA =1, Pathological stage IIB =1, Pathological l stage IIIA =1, Pathological stage IIIB =1, Pathological stage IIIC =2, Tumor marker ER negative=1 Tumor marker Grade3=1 Tumor marker ERBB2 negative=1

  6. Disease-free Survival (DFS)

    Time frame: Measured through 5 years after study enrollment

    DFS is defined as the time period between registration and first event

  7. Distant-disease- free survival (DDFS)

    Time frame: Measured through 5 years after study enrollment

    DDFS is defined as the time period between registration and first event

  8. Overall survival (OS)

    Time frame: Measured through 5 years after study enrollment

    OS is defined as the time period between registration and first event

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Neoadjuvant Apatinib Added to Weekly Paclitaxel and Cisplatin in Patient With Locally Advanced or Early Stage HER2 Negative Breast Cancer (APP) : a Open-label, Randomized, Controlled, Trial

Acronym: APP

Important dates

Study start
2018
Primary completion
2023
Study completion
2031
First posted
Jun 11, 2019
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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