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

NCT03270007 | Unknown Phase 4 DMC

• 1 other identifier: BCP19
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Breast Cancer

Outcome Measures

Primary Outcomes (1)

• distant disease-free survival (DDFS)

  5 years after surgery

Secondary Outcomes (1)

• relapse-free survival（RFS）、overall survival（OS）

  5 years after surgery

Study Arms (2)

Chemotherapy

EXPERIMENTAL

Drug: Vinorelbine

Control

NO INTERVENTION

Interventions

Vinorelbine DRUG

different from primary chemotherapy(containing anthracycline or paclitaxel)

Also known as: Intensive treatment

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥1500/mm3
• Platelets ≥100,000/ mm3
• Hemoglobin ≥10 g/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• Tao OUYANG: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

• Wang X, He Y, Li J, Wang T, Fan Z, Ouyang T. Intensive treatment of triple negative breast cancer with residual positive axillary lymph node after neoadjuvant chemotherapy. BMC Womens Health. 2024 Nov 27;24(1):629. doi: 10.1186/s12905-024-03441-0.

  PMID: 39604957 DERIVED

MeSH Terms

Interventions

Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Xing Wang, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xing Wang, MD

CONTACT

0086-10-88271119; wangxing_susu@sina.com

Ying-jian He, MD

CONTACT

0086-10-88271119; mimi487@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman of Breast Center

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: November 10, 2017
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

CN (1)