Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy

Tao OUYANG

Status and phase: Enrolling; Phase 4

Conditions: Primary Breast Cancer

Treatments: Drug: Vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT03270007

BCP19

Details and patient eligibility

About

This is a phase IV, single-center, prospective, open-label, randomized,controlled study

Enrollment: 304 estimated patients

Sex: Female

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients, 18≦age ≦66 years

• Biopsy proven lymph node positive, estrogen receptor<10%、progesterone receptor <10% and human epidermal growth factor receptor-2 negative primary breast cancer

• Must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel)

• Must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision

• Postoperative residual positive lymph nodes

• Adequate recovery from recent surgery

• No history of other malignancies

• No currently uncontrolled diseased or active infection

• Not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential

• Adequate cardiovascular function reserve with a myocardial infarction within the past six month

• without radiotherapy and chemotherapy contraindication

• Adequate hematologic function with:

  1. Absolute neutrophil count (ANC) ≥1500/mm3
  2. Platelets ≥100,000/ mm3
  3. Hemoglobin ≥10 g/dL

• Adequate hepatic and renal function with:

  1. Serum bilirubin ≤1.5×UNL
  2. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
  3. BUN between 1.7 and 8.3 mmol/L
  4. Cr between 40 and 110 umol/L

• Knowledge of the investigational nature of the study and Ability to give informed consent

• Ability and willingness to comply with study procedures.

Exclusion criteria

• Known or suspected distant metastases
• Concurrent malignancy or history of other malignancy
• Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
• Geographical, social, or psychological problems that would compromise study compliance
• Known or suspected hypersensitivity to vinorelbine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups

Chemotherapy

Experimental group

Treatment:

Drug: Vinorelbine

Control

No Intervention group