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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Trastuzumab

Docetaxel

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring trastuzumab, adjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

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

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

12 weeks adjuvant docetaxel plus trastuzumab

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Treatment-related adverse events

Incidence and severity of adverse events as assessed by NCI CTCAE V4.0

Change of LVEF after treatment

The change of LVEF after 12 weeks treatment compared to the baseline LVEF

Full Information

NCT ID

NCT03367676

First Posted

December 5, 2017

Last Updated

March 9, 2020

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03367676

Brief Title

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

Acronym

SOBER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 30, 2017 (Actual)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

trastuzumab, adjuvant therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Arm Description

12 weeks adjuvant docetaxel plus trastuzumab

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Docetaxel 100mg/m2，d1，iv，q3w*4

Primary Outcome Measure Information:

Title

Disease-free Survival

Description

Time Frame

3-year estimates

Secondary Outcome Measure Information:

Title

Breast Cancer Specific Survival

Description

Time Frame

3-year estimates

Title

Overall Survival

Description

Time Frame

3-year estimats

Title

Treatment-related adverse events

Description

Incidence and severity of adverse events as assessed by NCI CTCAE V4.0

Time Frame

up to 4 months

Title

Change of LVEF after treatment

Description

The change of LVEF after 12 weeks treatment compared to the baseline LVEF

Time Frame

up to 4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiayi Wu, doctor

Phone

8621-64370045

Ext

602268

pinkscorpio@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Zhu, doctor

Organizational Affiliation

Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shuning Ding, doctor

Phone

64370045

Ext

602215

nannanyard@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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