Clinical Trials /

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

NCT02464774

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 2014-FXY-093
  • NCT ID: NCT02464774

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Adjuvant ChemotherapyBreast-Conserving Therapy

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Breast-Conserving TherapyExperimentalPatients 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.
  • Adjuvant Chemotherapy
MastectomyActive ComparatorPatients 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.
  • Adjuvant Chemotherapy

Eligibility Criteria

        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.
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease-free survival(DFS)
Time Frame:Up to 5 years post-treatment
Safety Issue:
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.

Secondary Outcome Measures

Measure:Locoregional recurrence-free survival(LRRFS)
Time Frame:Up to 5 years post-treatment
Safety Issue:
Description:LRR refers to any progression in the breast/chest wall and/or regional lymph nodes.
Measure:Distant metastasis (DM)
Time Frame:Up to 5 years post-treatment
Safety Issue:
Description:DM is determined by clinical and radiographic means and/or histologically proven larger than 0.2mm.

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Xiaoming Xie

Trial Keywords

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

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