12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)

NCT03367676 | Unknown Phase 2

• 1 other identifier: RJBC1712
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.

Conditions

Breast Cancer

Keywords

trastuzumab; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  Estimated percentage of patients alive and disease-free at 3 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.

  3-year estimates

Secondary Outcomes (4)

• Breast Cancer Specific Survival

  3-year estimates

• Overall Survival

  3-year estimats

• Treatment-related adverse events

  up to 4 months

• Change of LVEF after treatment

  up to 4 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

12 weeks adjuvant docetaxel plus trastuzumab

Drug: Trastuzumab; Drug: Docetaxel

Interventions

Trastuzumab DRUG

Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.

Experimental Arm

Docetaxel DRUG

Docetaxel 100mg/m2，d1，iv，q3w\*4

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Women aged ≥18 years
• Have finished radical operation
• Pathologically confirmed dignosis of infiltrating primary breast cancer
• According to AJCC ,pT≤1cm, pN0,no evidence for metastasis
• Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be Her2 positive tumor (3+ by IHC or FISH+ )
• Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1,expected survival time \> 12 months
• Adequate bone marrow function,adequate liver and renal function,and adequate coagulation function.
• Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
• Written informed consent according to the local ethics committee requirements.

You may not qualify if:

• pT\>1cm or node positive
• Metastatic breast cancer
• Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
• With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
• Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
• Has symptomatic peripheral neuropathy \> grade 2 according to NCI
• Known severe allergy to any drugs in this study
• Has cadiac Dysfunction or lung dysfunction defined as follows:
• grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II
• angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms
• uncontrolled high-risk arryhthmia
• unconrolled hypertension
• Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
• Patient is pregnant or breast feeding

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Li Zhu, doctor

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayi Wu, doctor

CONTACT

8621-64370045; pinkscorpio@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: December 30, 2017
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)