Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Trial of Neoadjuvant Docetaxel ± Metronomic Capecitabine/CTX Followed by FEC in Women With Operable Triple Negative Breast Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02897050
• Other study ID #: BCCT2016001
• Status: Suspended
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: September 2024

Study information

• Verified date: April 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multi-center, open-label, phase II randomized controlled trial is to evaluate the efficacy of docetaxel(T) combined with metronomic cyclophosphamide/capecitabine (mCX) followed by fluorouracil /epirubicin/cyclophosphamide (FEC) versus T followed by FEC as neoadjuvant chemotherapy in treating women with triple negative breast cancer (TNBC), and to study the anti-tumor immune effect of metronomic neoadjuvant chemotherapy. 186 stage M0 TNBC patients who had a primary tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging are randomly enrolled to receive neoadjuvant T combined with mCX (3 cycles) followed by FEC (3 cycles) or T (3cycles) followed by FEC (3 cycles) before surgery. The primary end point is pathological complete response (pCR) rate, and the secondary end points include: clinical response rate, toxicities, breast-conserving rate, Ki67 and CD31 reduction rate, changes in the percentages of peripheral blood or tumor microenvironmental regulatory T cells (Treg), T helper cells (Th), CD8+ T cell, and tumor-specific CTL, and changes in tumor microenvironmental immune cytokines. Once there is a significant statistical difference in terms of pCR rate between two groups, 3-year disease-free survival (DFS) and 3-year overall survival (OS) will be included in the secondary end points. The aims of this study are to determine whether the neoadjuvant T combined with metronomic CX followed by FEC can significantly increase the pCR rate in TNBC with acceptable toxicity, and to explore the anti-tumor immune effect of metronomic neoadjuvant chemotherapy.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 170
• Est. completion date: September 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The patients signed the written informed consent
• The patients present with non-metastatic unilateral invasive ER-negative (IHC<10%), PR-negative(IHC<10%), HER2-negative breast cancer with a primary breast tumor > 2cm by imaging or an axillary lymph node > 2cm by imaging.
• 18 years old< age < 70 years old.
• The patients have no history of hormone therapy, chemotherapy, breast cancer surgery and radiotherapy.
• The patients have normal cardiac functions by echocardiography.
• The patients' ECOG scores are =2.
• The patients can swallow pills.
• The results of patients' blood tests are as follows:
• Hb=90g/L;
• WBC=4E+9/L;
• Plt=100E+9/L;
• Neutrophils=1.5E+9/L;
• ALT and AST = triple of normal upper limit;
• TBIL = 1.5 times of normal upper limit;
• Creatinine = 1.5 times of normal upper limit.

Exclusion Criteria:

• The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;
• The patients have active infections that were not suitable for chemotherapy;
• The patients have severe non-cancerous diseases.
• The patients have bilateral breast cancers or male breast cancers or inflammatory breast cancers.
• The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
• The patients are in some special conditions that they cannot understand the written informed consent, such as they are demented or hawkish.
• The patients have allergic history or contraindication of any of the interventional drugs.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1
• Capecitabine
Capecitabine 1200mg/m2/d, po, d1-d21
• Cyclophosphamide (tablet)
Cyclophosphamide 50 mg/d, po, d1-d21
• Fluorouracil
Fluorouracil 500mg/m2, iv, d1
• Epirubicin
Epirubicin 100mg/m2, iv, d1
• Cyclophosphamide (injection)
Cyclophosphamide 500mg/m2, iv, d1

Locations

Country	Name	City	State
China	Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Xinjiang Medical School Cancer Hospital	Urumqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (pCR) rate		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Ultrasound response rate		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Breast-conserving surgery rate		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		during on-neoadjuvant therapy period (defined as the period from the first dose of study medication up to 30 days of the last dose)
Secondary	Tumor Ki67 reduction rate in relation to neoadjuvant therapy		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Tumor CD31 reduction rate in relation to neoadjuvant therapy		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Peripheral blood CD8+ T cell percentage change in relation to neoadjuvant therapy		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Peripheral blood regulatory T cell percentage change in relation to neoadjuvant therapy		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Peripheral blood tumor specific T cell (CTL) percentage change in relation to neoadjuvant therapy		at definitive surgery (20-24 weeks after the first dose of study medication)
Secondary	Peripheral blood T helper cell percentage change in relation to neoadjuvant therapy		at definitive surgery (20-24 weeks after the first dose of study medication)