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Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

Primary Purpose

Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Duct Carcinoma of Breast

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Paclitaxel, Cisplatin

EC to docetaxel or paclitaxel

About this trial

This is an interventional treatment trial for Tubular Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women aged ≥18 years and ≤70 years
Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma
Not received treatment for breast cancer before operation
Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and Ki - 67 >20% or tumor size ≥2 cm and grade III or tumor size ≥2cm and aged <35 years
HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified
Performance status (PS) 0-1
Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit
No obvious main organs dysfunction

Exclusion Criteria:

metastatic breast cancer
Patient is pregnant or breast feeding
Any evidence of sense or motor nerve disorders
Bilateral Primary Breast Cancer (DCIS in one side not included)
Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection
Have received chemotherapy because of any malignancy other than breast cancer
Known severe hypersensitivity to any drugs in this study

Sites / Locations

Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

paclitaxel and cisplatin

epirubicin and cyclophosphamide

Arm Description

Drug: paclitaxel, cisplatin, epirubicin and cyclophosphamide Patients will be administered paclitaxel (80 mg/m² i.v. given weekly on day 1 q day 8 for 12 weeks) and cisplatin (25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 3 cycles) followed by epirubicin and cyclophosphamide (EC) (epirubicin 90mg/m² i.v.d1, cyclophosphamide 600mg/m² i.v.d1) for 4 cycles.

Drug：epirubicin, cyclophosphamide, paclitaxel and docetaxel Investigators will declare one of the following regimens: Patients with hormone receptor (HR) positive breast cancer wil be administered epirubicin (90mg/m² i.v.d1 q21d) and cyclophosphamide (600mg/m² i.v.d1 q21d) for 4 cycles followed by docetaxel (75mg/m² i.v.d1 q21d) for 4 cycles. Patients with triple-negative breast cancer will be administered epirubicin (90mg/m² i.v.d1 q21d) and cyclophosphamide (600mg/m² i.v.d1 q21d) for 4 cycles followed by weekly paclitaxel (80 mg/m² i.v.d1) for 12 weeks or docetaxel (75mg/m² i.v.d1 q21d) for 4 cycles.

Outcomes

Primary Outcome Measures

Number of Participants With Disease-Free Survival (DFS) Events

DFS is defined as the time period between registration and first event

Secondary Outcome Measures

Number of Participants With Overall Survival (OS) Events

OS is defined as the time period between registration and first event

Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.

Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped

Full Information

NCT ID

NCT03201861

First Posted

June 8, 2017

Last Updated

September 21, 2021

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03201861

Brief Title

Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

Official Title

Phase 3 Study of Weekly Paclitaxel in Combination With Cisplatin as Adjuvant Chemotherapy for Early Stage Human Epidermal Growth Factor Receptor-2 (HER2) Negative Breast Cancer in High-risk Women

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 27, 2017 (Actual)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .

Detailed Description

In this trial, patients will be randomly assigned in a 2:1 ratio to receive cisplatin-based adjuvant chemotherapy and to standard adjuvant chemotherapy.

6. Conditions and Keywords

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

Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Duct Carcinoma of Breast

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

762 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

paclitaxel and cisplatin

Arm Type

Experimental

Arm Description

Arm Title

epirubicin and cyclophosphamide

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel, Cisplatin

Other Intervention Name(s)

Taxol

Intervention Description

weekly paclitaxel and cisplatin

Intervention Type

Drug

Intervention Name(s)

EC to docetaxel or paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

Standard adjuvant chemotherapy recommended by guideline

Primary Outcome Measure Information:

Title

Number of Participants With Disease-Free Survival (DFS) Events

Description

DFS is defined as the time period between registration and first event

Time Frame

up to 5 year follow up

Secondary Outcome Measure Information:

Title

Number of Participants With Overall Survival (OS) Events

Description

OS is defined as the time period between registration and first event

Time Frame

up to 5 year follow up

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.

Description

Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped

Time Frame

5 months during adjuvant therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women aged ≥18 years and ≤70 years Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma Not received treatment for breast cancer before operation Triple-negative breast cancer confirmed by pathology, or pathology confirmed as the HR positive breast cancer at the same time meet the following conditions: axillary lymph node positive breast cancer, tumor size≥2 cm and Ki - 67 >20% or tumor size ≥2 cm and grade III or tumor size ≥2cm and aged <35 years HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified Performance status (PS) 0-1 Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit , creatinine≤1.5 upper normal limit, bilirubin≤1.5 upper normal limit No obvious main organs dysfunction Exclusion Criteria: metastatic breast cancer Patient is pregnant or breast feeding Any evidence of sense or motor nerve disorders Bilateral Primary Breast Cancer (DCIS in one side not included) Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection Have received chemotherapy because of any malignancy other than breast cancer Known severe hypersensitivity to any drugs in this study

Central Contact Person:

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

Yueyao Du, M.D.

Phone

86-21-68385569

jessicayy8629@126.com

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

Jie Zhang, M.D.

Phone

86-21-68385516

doudou090227@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinsong Lu, M.D.

Organizational Affiliation

Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji Hospital, School of Medicine, Shanghai Jiaotong University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yueyao Du, M.D.

Phone

86-21-68385569

jessicayy8629@126.com

First Name & Middle Initial & Last Name & Degree

Jie Zhang, M.D.

Phone

86-21-68385516

doudou090227@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26077235

Citation

Sparano JA, Zhao F, Martino S, Ligibel JA, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Long-Term Follow-Up of the E1199 Phase III Trial Evaluating the Role of Taxane and Schedule in Operable Breast Cancer. J Clin Oncol. 2015 Jul 20;33(21):2353-60. doi: 10.1200/JCO.2015.60.9271. Epub 2015 Jun 15.

Results Reference

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Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

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