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

NCT02464774 | Unknown DMC

• 1 other identifier: 2014-FXY-093
• Study Type: interventional
• Target: 464
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Locoregional recurrence-free survival(LRRFS)

  Up to 5 years post-treatment

• Distant metastasis (DM)

  Up to 5 years post-treatment

Study Arms (2)

Breast-Conserving Therapy

EXPERIMENTAL

1. Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins. 2. 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. 3. 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.

Procedure: Breast-Conserving Therapy; Drug: Adjuvant Chemotherapy; Radiation: Radiation Therapy

Mastectomy

ACTIVE COMPARATOR

1. Patients undergo mastectomy (MT) with surgical axillary staging. 2. 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.

Procedure: Mastectomy; Drug: Adjuvant Chemotherapy

Interventions

Breast-Conserving Therapy PROCEDURE

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

Breast-Conserving Therapy

Mastectomy PROCEDURE

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

Mastectomy

Adjuvant Chemotherapy DRUG

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

Breast-Conserving Therapy; Mastectomy

Radiation Therapy RADIATION

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.

Breast-Conserving Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaoming Xie: lead

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Recurrence

Interventions

Mastectomy, Segmental; Mastectomy; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Department of Breast Surgical Oncology,Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2022
• Last Updated: June 8, 2015

Record last verified: 2015-06