Breast-Conserving Therapy in Patients With Triple-Negative Breast Cancer

Breast Cancer Clinical Trial

Official title:

Impact of Breast-Conserving Therapy (BCT) on Recurrence in Patients With Triple-Negative Breast Cancer (TNBC) Compared With Mastectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02464774
• Other study ID #: 2014-FXY-093
• Status: Not yet recruiting
• Phase: N/A
• First received: June 1, 2015
• Last updated: June 3, 2015
• Start date: July 2015

Study information

• Verified date: June 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Triple-negative breast cancer (TNBC) is an aggressive subtype shown to have a high risk of locoregional recurrence (LRR) and distant metastasis (DM). The equivalent impact of breast-conserving therapy (BCT) and mastectomy on disease-free survival in patients with early breast cancer has been established by a number of large randomized controlled trials and meta-analysis. However, ongoing dispute exists on whether TNBC is a good candidate for BCT.

PURPOSE: This prospective, randomized, open, single-center Phase III clinical study is conducted to compare efficacy and safety of breast-conserving therapy and mastectomy in treating Chinese patients with early TNBC.

Description:

STUDY POPULATION:

Operable patients with T1-2N0-1M0 triple-negative breast cancer

OBJECTIVES:

Primary To assess the impact of breast-conserving therapy on disease-free survival compared with mastectomy in patients with T1-2N0-1M0 triple-negative breast cancer.

Secondary To assess the impact of breast-conserving therapy on locoregional recurrence-free survival (LRRFS) and distant metastasis-free survival (DMFS) compared with mastectomy in patients with T1-2N0-1M0 triple-negative breast cancer.

OUTLINE:

This is a prospective, randomized, open, single-center Phase III clinical study.

Patients undergo either lumpectomy or mastectomy with surgical axillary staging with all lesions resected to negative margins based on the results of randomization generated by computer.

Patients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen respectively.

Since all tumors are smaller than 5cm and metastatic lymph nodes are less than 4, patients undergoing mastectomy do not receive radiation therapy. On the hand, within 4-8 weeks after completion of chemotherapy, patients undergoing breast-conserving surgery receive radiation therapy as follows: (1) N0: Radiation therapy to whole breast (+boost to tumor bed) or consideration of partial breast irradiation in selected patients; (2) N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.

After completion of study treatment, patients are followed up every 3 months for 2 years and then 6 months for years 3-5.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 464
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Female aged 18 - 65 years old;

2. Staging of Cancer: cT1-2N0-1M0;

3. Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);

4. Definite reports on ER/PR/Her2 receptor showing all ER/PR/Her2 negative (specific definitions: immunohistochemical detection of ER <10% tumor cells is defined as ER negative, PR <10% positive tumor cells is defined as PR-negative, Her2 is 0~1+ or 2+ but determined negative via FISH or CISH detected (no amplification) is defined as Her2 negative);

5. Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;

6. ECOG performance score is 0 or 1;

7. No mass or microscopic tumor residue after surgery resection;

8. Informed consent form signed.

9. Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study.

Exclusion Criteria:

1. Bilateral breast cancer;

2. Clinical or radiographic evidence of metastatic disease;

3. Widespread disease that cannot be incorporated by local excision through a single incision that achieves negative margins with a satisfactory cosmetic result;

4. Diffuse suspicious or malignant-appearing microcalcifications;

5. Positive pathologic margin;

6. Any of ER, PR or Her2 is positive;

7. Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;

8. Prior history of breast cancer or any other malignant disease (except for basal cell carcinoma and cervical carcinoma in situ);

9. Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study;

10. Known allergic to taxane and anthracycline agents;

11. Pregnant and breast-feeding women;

12. With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups;

13. Without personal freedom and independent civil capacity.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Procedure:
• Breast-Conserving Therapy
Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.
• Mastectomy
Patients undergo mastectomy with surgical axillary staging with all lesions resected to negative margins.

Drug:
• Adjuvant Chemotherapy
Patients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen respectively.

Radiation:
• Radiation Therapy
N0: Radiation therapy to whole breast (+boost to tumor bed) or consideration of partial breast irradiation in selected patients; (2) N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoming Xie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival(DFS)	DFS is defined as time (measured in months) from initial local-regional surgical treatment until first recurrence (local or distant) or last follow-up.	Up to 5 years post-treatment	No
Secondary	Locoregional recurrence-free survival(LRRFS)	LRR refers to any progression in the breast/chest wall and/or regional lymph nodes.	Up to 5 years post-treatment	Yes
Secondary	Distant metastasis (DM)	DM is determined by clinical and radiographic means and/or histologically proven larger than 0.2mm.	Up to 5 years post-treatment	No