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

12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Tumors ≤1cm, Node-negative, HER2-positive Breast cancER (SOBER):a Single-grouparm, Open-label, Prospective, Phase 2 Study

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab; Drug: Docetaxel

Detailed Description

Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study 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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiayi Wu, doctor; Phone Number: 602268 8621-64370045; Email: pinkscorpio@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Contact: Shuning Ding, doctor; Phone Number: 602215 64370045; Email: nannanyard@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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:

1. grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II
2. angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms
3. uncontrolled high-risk arryhthmia
4. 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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; 12 weeks adjuvant docetaxel plus trastuzumab	Drug: Trastuzumab; Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.; Drug: Docetaxel; Docetaxel 100mg/m2，d1，iv，q3w*4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Cancer Specific Survival	Estimated percentage of patients alive and disease-free at 3 years from randomization, where breast cancer specific survival is defined as the time from randomization to death from breast cancer relapse; or censored at date last known alive.	3-year estimates
Overall Survival	Estimated percentage of patients alive and disease-free at 3 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.	3-year estimats
Treatment-related adverse events	Incidence and severity of adverse events as assessed by NCI CTCAE V4.0	up to 4 months
Change of LVEF after treatment	The change of LVEF after 12 weeks treatment compared to the baseline LVEF	up to 4 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Li Zhu, doctor, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2017
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: adjuvant therapy; trastuzumab
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Trastuzumab
• Other Study ID Numbers: RJBC1712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No