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

June 3, 2015 updated by: Xiaoming Xie

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
464

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Breast-Conserving Therapy
  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
Patients undergo lumpectomy 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.
ACTIVE_COMPARATOR: Mastectomy
  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.
Drug: Adjuvant Chemotherapy
Patients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen respectively.
Procedure: Mastectomy
Patients undergo mastectomy with surgical axillary staging with all lesions resected to negative margins.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-free survival(DFS)
Time Frame: Up to 5 years post-treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Locoregional recurrence-free survival(LRRFS)
Time Frame: Up to 5 years post-treatment
LRR refers to any progression in the breast/chest wall and/or regional lymph nodes.
Up to 5 years post-treatment
Distant metastasis (DM)
Time Frame: Up to 5 years post-treatment
DM is determined by clinical and radiographic means and/or histologically proven larger than 0.2mm.
Up to 5 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiaoming Xie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-FXY-093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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