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

Mucinous Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03201861
• Other study ID #: SHPD004
• Status: Recruiting
• Phase: Phase 3
• Start date: July 27, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: RenJi Hospital
• Contact: Yueyao Du, M.D.
• Phone: 86-21-68385569
• Email: jessicayy8629[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 762
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Invasive Duct Carcinoma of Breast
• Mucinous Breast Cancer
• Tubular Breast Cancer

Intervention

Drug:
• Paclitaxel, Cisplatin
weekly paclitaxel and cisplatin
• EC to docetaxel or paclitaxel
Standard adjuvant chemotherapy recommended by guideline

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Overall Survival (OS) Events	OS is defined as the time period between registration and first event	up to 5 year follow up
Secondary	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	5 months during adjuvant therapy