Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast Cancer

NCT ID: NCT03735082

Last Updated: 2018-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-06-01

Brief Summary

The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients

Detailed Description

Triple-negative breast cancer (TNBC) has the characteristics of early onset, high malignancy, less treatment, and resistance to treatment. Advanced patients have shorter survival than other subtypes. Changes in traditional chemotherapy regimens for breast cancer (ie, the addition of carboplatin) are potential ways to improve patient outcomes. Although anthracyclines and cyclophosphamide play a very positive role in the treatment of breast cancer, there are also small and serious long-term risks. Anti-angiogenic drugs are currently one of the few targeted therapies that have achieved some efficacy in TNBC. Apatinib, a targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with breast cancer. Considering of current status of anti-angiogenic drugs in the field of breast cancer, results of apatinib in advanced breast cancer, and current unmet clinical needs, the investigator conducted this study to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib+Paclitaxel+Carboplatin

apatinib 250mg, d1-14,14day/cycle; Paclitaxel 175mg/m2,d1,14days/cycle; Carboplatin AUC=4,d1,14day/cycle

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

apatinib 250mg,qd,d1-14,14day/cycle

Paclitaxel

Intervention Type: DRUG

paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle

Carboplatin

Intervention Type: DRUG

carboplatin AUC=4,d1,14day/cycle;

Interventions

Apatinib

apatinib 250mg,qd,d1-14,14day/cycle

Intervention Type: DRUG

Paclitaxel

paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle

Intervention Type: DRUG

Carboplatin

carboplatin AUC=4,d1,14day/cycle;

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 75 year-old women;

2. Physical condition ECOG PS: 0-1;

3. Previously untreated, histologically or cytologically confirmed to be triple negative breast cancer;

4. Breast mass > 2cm, or ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicle); Note: According to RECIST version 1.1, confirmed by CT or MRI,There must be at least one measurable lesion;If the target lesion is a lymph node requiring a short diameter greater than 1.5 cm, and the target lesion is not suitable for surgical treatment;

5. Laboratory tests meet the following criteria: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥10g/dl; serum bilirubin ≤ 1.5 times the upper limit of normal value; AKP,ALT and AST≤2.5 times the upper limit of normal value;AKP, ALT and AST≤5 times the upper limit of normal value when liver metastasis;Urea nitrogen ≤ 1.5 times the upper limit of normal value,serum creatinine ≤ 1.5 times the upper limit of normal value;

6. Expected survival time ≥ 3 months;

7. Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial;

8. Patients volunteered to join the study and signed informed consent.

Exclusion Criteria

1. There are other metastasis sites other than ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicular);

2. Have received anti-tumor treatment;

3. Patients with hypertension who are not well controlled by antihypertensive medication (systolic pressure >140 mmHg, diastolic pressure >90 mmHg); have uncontrolled or severe cardiovascular disease, such as Refractory angina pectoris,congestive heart failure occurred within 6 months prior to screening ; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, prolonged QT interval; history of cerebrovascular accident, symptomatic and medication required Coronary heart disease;

4. Significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);

5. Patients with previous bleeding history, clinically significant bleeding symptoms, and patients with clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + and above, vasculitis, etc.; urine protein positive patients;

6. Major surgery or severe traumatic injury, fracture, or poor healing wound within 4 weeks;

7. Allergic to apatinib and/or its adjuvants, paclitaxel, carboplatin, etc.;

8. Female patients during pregnancy or lactation, female patients with fertility and pregnancy test positive, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period

9. The patient has a severe concomitant disease, or any other condition the investigator believes is not suitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Li Qiao

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiao Li

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Binghe Xu

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Binghe Xu

Role: CONTACT

xubinghe@medmall.com

86-87788826 ext. 861087788120

Qiao Li

Role: CONTACT

Liqiaopumc@qq.com

86-87788120 ext. 861087788120

Facility Contacts

Qiao LI, MD

Role: primary

liqiaopumc@yahoo.cn

86-10-87788120

Binghe XU, MD, PHD

Role: backup

xubinghe@medmail.com.cn

86-10-87788495

References

Liu J, He M, Ou K, Wang X, Wang Y, Qi L, Chai Y, Jiang M, Ma F, Luo Y, Yuan P, Zhang P, Xu B, Li Q. Efficacy and safety of apatinib combined with dose-dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple-negative breast cancer: A prospective cohort study with propensity-matched analysis. Int J Cancer. 2024 Jan 1;154(1):133-144. doi: 10.1002/ijc.34717. Epub 2023 Sep 7.

Reference Type: DERIVED

PMID: 37676110 (View on PubMed)

Other Identifiers

LQ004

Identifier Type: -

Identifier Source: org_study_id