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

NCT ID: NCT03201861

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 762 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

paclitaxel and cisplatin

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.

Group Type: EXPERIMENTAL

Paclitaxel, Cisplatin

Intervention Type: DRUG

weekly paclitaxel and cisplatin

epirubicin and cyclophosphamide

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.

Group Type: ACTIVE_COMPARATOR

EC to docetaxel or paclitaxel

Intervention Type: DRUG

Standard adjuvant chemotherapy recommended by guideline

Interventions

Paclitaxel, Cisplatin

weekly paclitaxel and cisplatin

Intervention Type: DRUG

EC to docetaxel or paclitaxel

Standard adjuvant chemotherapy recommended by guideline

Intervention Type: DRUG

Other Intervention Names

Taxol; Taxol

Eligibility Criteria

Inclusion Criteria

1. Women aged ≥18 years and ≤70 years

2. Have accepted surgical treatment, histologically confirmed early breast cancer, the pathological types of invasive carcinoma

3. Not received treatment for breast cancer before operation

4. 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

5. HER2 negative: immunohistochemistry HER2 (1 +) or HER2 (0), or fluorescence in situ hybridization (FISH): not amplified

6. Performance status (PS) 0-1

7. 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

8. No obvious main organs dysfunction

Exclusion Criteria

1. metastatic breast cancer

2. Patient is pregnant or breast feeding

3. Any evidence of sense or motor nerve disorders

4. Bilateral Primary Breast Cancer (DCIS in one side not included)

5. Patients with medical conditions taht indicate intolerant to adjuvant chemotherapy, including uncontrolled cardiovascular disease, severe infection

6. Have received chemotherapy because of any malignancy other than breast cancer

7. Known severe hypersensitivity to any drugs in this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinsong Lu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yueyao Du, M.D.

Role: CONTACT

jessicayy8629@126.com

86-21-68385569

Jie Zhang, M.D.

Role: CONTACT

doudou090227@163.com

86-21-68385516

Facility Contacts

Yueyao Du, M.D.

Role: primary

jessicayy8629@126.com

86-21-68385569

Jie Zhang, M.D.

Role: backup

doudou090227@163.com

86-21-68385516

References

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.

Reference Type: BACKGROUND

PMID: 26077235 (View on PubMed)

Other Identifiers

SHPD004

Identifier Type: -

Identifier Source: org_study_id