Clinical trial NCT03982485: Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Apatinib
Neoadjuvant chemotherapy
Breast cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Pregnant or breastfeeding patients
3. Metastatic or recurrent patients
4. Any evidence of sense or motor nerve disorders
5. Any concurrent malignancy other than breast cancer
6. 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
7. Inability to swallow, gastrointestinal resection, chronic diarrhea and obstruction of the intestine, various factors which affect drug use and absorption
8. Coagulation disorders
9. Artery or venous thrombosis occurred within 6 months before the study begins
10. Have received prior treatment with a VEGFR TKI

Primary outcomes:
measure: Residual cancer burden (RCB 0-I rates）
timeFrame: Time of surgery
measure: Pathologic Complete Response (pCR) of the Primary Tumor in the Breast
timeFrame: Time of surgery
Secondary outcomes:
measure: pCR in the Breast and Nodes
timeFrame: Time of surgery
measure: Near pCR in the Breast
timeFrame: Time of surgery
measure: Clinical and imaging response
timeFrame: Time of surgery
measure: Number of Participants With Drug Related Treatment Adverse Events
timeFrame: an average of 16 weeks
measure: Neo-bioscore
timeFrame: Time of surgery
measure: Disease-free Survival (DFS)
timeFrame: Measured through 5 years after study enrollment
measure: Distant-disease- free survival (DDFS)
timeFrame: Measured through 5 years after study enrollment
measure: Overall survival (OS)
timeFrame: Measured through 5 years after study enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Jinsong Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: