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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Breast-Conserving Therapy

Mastectomy

Adjuvant Chemotherapy

Radiation Therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Triple-Negative Breast Cancer, Breast-Conserving Therapy, Mastectomy, Recurrence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female aged 18 - 65 years old;
Staging of Cancer: cT1-2N0-1M0;
Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
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);
Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
ECOG performance score is 0 or 1;
No mass or microscopic tumor residue after surgery resection;
Informed consent form signed.
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:

Bilateral breast cancer;
Clinical or radiographic evidence of metastatic disease;
Widespread disease that cannot be incorporated by local excision through a single incision that achieves negative margins with a satisfactory cosmetic result;
Diffuse suspicious or malignant-appearing microcalcifications;
Positive pathologic margin;
Any of ER, PR or Her2 is positive;
Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
Prior history of breast cancer or any other malignant disease (except for basal cell carcinoma and cervical carcinoma in situ);
Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study;
Known allergic to taxane and anthracycline agents;
Pregnant and breast-feeding women;
With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups;
Without personal freedom and independent civil capacity.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breast-Conserving Therapy

Mastectomy

Arm Description

Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins. Within 4-8 weeks after surgery, patients receive adjuvant chemotherapy as follows: TC for stage I: Docetaxel 75 mg/m + Cyclophosphamide 600 mg/m, cycled every 21 days for 4 cycles. TAC for stage II: Docetaxel 75 mg/m + Doxorubicin 50 mg/m + Cyclophosphamide 500 mg/m, cycled every 21 days for 6 cycles. Within 4-8 weeks after completion of chemotherapy, patients undergo radiation therapy as follows: N0: Radiation therapy to whole breast (+boost to tumor bed). N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.

Patients undergo mastectomy (MT) with surgical axillary staging. Within 4-8 weeks after surgery, patients receive adjuvant chemotherapy as follows: TC for stage I: Docetaxel 75 mg/m + Cyclophosphamide 600 mg/m, cycled every 21 days for 4 cycles. TAC for stage II: Docetaxel 75 mg/m + Doxorubicin 50 mg/m + Cyclophosphamide 500 mg/m, cycled every 21 days for 6 cycles.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Locoregional recurrence-free survival(LRRFS)

LRR refers to any progression in the breast/chest wall and/or regional lymph nodes.

Distant metastasis (DM)

DM is determined by clinical and radiographic means and/or histologically proven larger than 0.2mm.

Full Information

NCT ID

NCT02464774

First Posted

June 1, 2015

Last Updated

June 3, 2015

Sponsor

Xiaoming Xie

1. Study Identification

Unique Protocol Identification Number

NCT02464774

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaoming Xie

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Triple-Negative Breast Cancer, Breast-Conserving Therapy, Mastectomy, Recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

464 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Breast-Conserving Therapy

Arm Type

Experimental

Arm Description

Arm Title

Mastectomy

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Breast-Conserving Therapy

Intervention Description

Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.

Intervention Type

Procedure

Intervention Name(s)

Mastectomy

Intervention Description

Patients undergo mastectomy with surgical axillary staging with all lesions resected to negative margins.

Intervention Type

Drug

Intervention Name(s)

Adjuvant Chemotherapy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease-free survival(DFS)

Description

DFS is defined as time (measured in months) from initial local-regional surgical treatment until first recurrence (local or distant) or last follow-up.

Time Frame

Up to 5 years post-treatment

Secondary Outcome Measure Information:

Title

Locoregional recurrence-free survival(LRRFS)

Description

LRR refers to any progression in the breast/chest wall and/or regional lymph nodes.

Time Frame

Up to 5 years post-treatment

Title

Distant metastasis (DM)

Description

DM is determined by clinical and radiographic means and/or histologically proven larger than 0.2mm.

Time Frame

Up to 5 years post-treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female aged 18 - 65 years old; Staging of Cancer: cT1-2N0-1M0; Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable); 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); Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery; ECOG performance score is 0 or 1; No mass or microscopic tumor residue after surgery resection; Informed consent form signed. 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: Bilateral breast cancer; Clinical or radiographic evidence of metastatic disease; Widespread disease that cannot be incorporated by local excision through a single incision that achieves negative margins with a satisfactory cosmetic result; Diffuse suspicious or malignant-appearing microcalcifications; Positive pathologic margin; Any of ER, PR or Her2 is positive; Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy; Prior history of breast cancer or any other malignant disease (except for basal cell carcinoma and cervical carcinoma in situ); Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study; Known allergic to taxane and anthracycline agents; Pregnant and breast-feeding women; With mental illness and cognitive impairment, unable to understand trial protocol and side effects and complete trial protocol and follow-ups; Without personal freedom and independent civil capacity.

12. IPD Sharing Statement

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

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