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

NCT03201861 | Recruiting Phase 3

• 1 other identifier: SHPD004
• Study Type: interventional
• Target: 762
• Locations: 1 country
• Sites: 1

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 .

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  up to 5 year follow up

Secondary Outcomes (2)

• Number of Participants With Overall Survival (OS) Events

  up to 5 year follow up

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

  5 months during adjuvant therapy

Study Arms (2)

paclitaxel and cisplatin

EXPERIMENTAL

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: Paclitaxel, Cisplatin

epirubicin and cyclophosphamide

ACTIVE COMPARATOR

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.

Drug: EC to docetaxel or paclitaxel

Interventions

Paclitaxel, Cisplatin DRUG

weekly paclitaxel and cisplatin

Also known as: Taxol

paclitaxel and cisplatin

EC to docetaxel or paclitaxel DRUG

Standard adjuvant chemotherapy recommended by guideline

Also known as: Taxol

epirubicin and cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 26077235 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Ductal, Breast

Interventions

TP protocol; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jinsong Lu, M.D.

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueyao Du, M.D.

CONTACT

86-21-68385569; jessicayy8629@126.com

Jie Zhang, M.D.

CONTACT

86-21-68385516; doudou090227@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 28, 2017
• Study Start: July 27, 2017
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)