Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

Inflammatory Breast Cancer Clinical Trial

— SHPD002  

Official title:

A Prospective, Randomized, Open-label Comparison of Preoperative Weekly Paclitaxel and Cisplatin With or Without Endocrine Therapy in Patients With Operable Hormone Receptor Positive and Triple Negative Locally Advanced Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02221999
• Other study ID #: RenJiH-BC-002
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 2013
• Est. completion date: January 2029

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate. Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.

Description:

In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy. Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: January 2029
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women aged =18years and =70 years;

2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size =2 cm, T2-4 N0-3M0;

3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as >1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals >2.0 or HER2 gene copy >6.0.

4. No prior systemic or loco-regional treatment of breast cancer;

5. 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 (UNL), creatinine=1.5 UNL, bilirubin=1.5UNL;

6. No obvious main organs dysfunction.

Exclusion Criteria:

1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;

2. Patient is pregnant or breast feeding;

3. Inflammatory breast cancer and metastatic breast cancer;

4. Any evidence of sense or motor nerve disorders;

5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;

6. Any concurrent malignancy other than breast cancer;

7. Know severe hypersensitivity to any drugs in this study.

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Ductal, Breast
• Inflammatory Breast Cancer
• Invasive Ductal Breast Cancer
• Mucinous Breast Cancer
• Tubular Breast Cancer

Intervention

Drug:
• Paclitaxel

• Cisplatin

• Gonadotropin-releasing hormone agonist
Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m
• Letrozole

Locations

Country	Name	City	State
China	HanDan Central Hospital	Handan	Hebei
China	The First Affiliated Hospital of University of South China	Hengyang	Hunan
China	Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage	Hohhot	Inner Mongolia
China	The second people's hospital of Kunshan city	Kunshan	Jiangsu
China	Armed Police Corps Hospital of Shanghai	Shanghai	Shanghai
China	Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai
China	Yueyang hospital of integrated traditional Chinese and Western medine	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai
China	Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital	Shenzhen	Guangdong
China	Department of Medical Oncology, General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Zhoushan hospital	Zhoushan	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete remission rate	Pathological complete remission is defined as no invasive cancer in breast and axillary nodes.	after 4 months preoperative treatment
Secondary	Number of Participants With Drug Related Treatment Adverse Events	Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state.	4 months during neoadjuvant therapy
Secondary	Clinical and imaging response	To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment	4 months during treatment
Secondary	disease free survival (DFS)	DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause.	5 years
Secondary	regional recurrence free survival (RRFS)	RRFS is defined as the time period between registration and first event	5 years
Secondary	local recurrence free survival (LRFS)	LRFS is defined as the time period between registration and first event	5 years
Secondary	overall survival (OS)	OS is defined as the time period between registration and first event	5 years
Secondary	distant-disease- free survival (DDFS)	DDFS is defined as the time period between registration and first event	5 years
Secondary	rate of tumor remission (RTR)	RTR is defined as the proportion of tumor remission per unit time	after 2 cycles and 4 cycles during neoadjuvant therapy
Secondary	serum markers	Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery	Pre-treatment and/or surgical
Secondary	molecular markers	Pre-treatment and surgical expression of molecular markers (LHRHa receptor, EGFR,PD-L1)	Pre-treatment and/or surgical