Breast CancerNCT02464774
Breast-Conserving Therapy in Patients With Triple-Negative Breast Cancer
A study testing Breast-Conserving Therapy, Mastectomy and Adjuvant Chemotherapy in people with Breast Cancer, run by Xiaoming Xie.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast-Conserving Therapy, Mastectomy and Adjuvant Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Breast-Conserving Therapy, Mastectomy, Adjuvant Chemotherapy, Radiation Therapy
- Keywords
- Breast Cancer, Triple-Negative Breast Cancer, Breast-Conserving Therapy, Mastectomy, Recurrence
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast-Conserving TherapyProcedure or surgery
Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.
MastectomyProcedure or surgery
Patients undergo mastectomy with surgical axillary staging with all lesions resected to negative margins.
Adjuvant ChemotherapyDrug
Patients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen respectively.
Radiation TherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Mastectomy; Drug: Adjuvant Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years post-treatment
Secondary outcomes (2)
Locoregional recurrence-free survival(LRRFS)
LRR refers to any progression in the breast/chest wall and/or regional lymph nodes.
Measured: Up to 5 years post-treatment
Distant metastasis (DM)
DM is determined by clinical and radiographic means and/or histologically proven larger than 0.2mm.
Measured: Up to 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoming Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoming Xie, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464774
- Sponsor's protocol ID
- 2014-FXY-093
- Status last verified
- Jun 2015
- First submitted
- 1 Jun 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breast-Conserving Therapy (BCT) on Recurrence in Patients With Triple-Negative Breast Cancer (TNBC) Compared With Mastectomy
- ClinicalTrials.gov ID
- NCT02464774
- Acronym / sponsor ID
- 2014-FXY-093
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Triple-Negative Breast Cancer, Breast-Conserving Therapy, Mastectomy, Recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Xiaoming XieUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2022 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast-Conserving Therapy | Experimental | Procedure: Breast-Conserving Therapy, Drug: Adjuvant Chemotherapy, Radiation: Radiation Therapy1. 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. |
| Mastectomy | Active comparator | Procedure: Mastectomy, Drug: Adjuvant Chemotherapy1. 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast-Conserving TherapyPatients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins. | Procedure or surgery | Breast-Conserving Therapy |
| MastectomyPatients undergo mastectomy with surgical axillary staging with all lesions resected to negative margins. | Procedure or surgery | Mastectomy |
| Adjuvant ChemotherapyPatients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen respectively. | Drug | Breast-Conserving Therapy, Mastectomy |
| Radiation TherapyN0: 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. | Radiation | Breast-Conserving Therapy |
Primary outcome
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.
2 secondary outcomes
Locoregional recurrence-free survival(LRRFS)
Time frame: Up to 5 years post-treatment
Distant metastasis (DM)
Time frame: Up to 5 years post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Breast-Conserving Therapy, Mastectomy and Adjuvant Chemotherapy in people with Breast Cancer, run by Xiaoming Xie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival(DFS) (time frame: Up to 5 years post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.