Clinical trial · Interventional

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

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

NCT02464774CI-TRIAL-00018191unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Adjuvant Chemotherapy	Drug	Adjuvant Chemotherapy	ALIAS
Breast-Conserving Therapy	Procedure	—	UNRESOLVED
Mastectomy	Procedure	—	UNRESOLVED
Radiation Therapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Breast-Conserving Therapy
description
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.
interventionNames
1. Procedure: Breast-Conserving Therapy
2. Drug: Adjuvant Chemotherapy
3. Radiation: Radiation Therapy
type
ACTIVE_COMPARATOR
label
Mastectomy
description
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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.