Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
155

Inclusion Criteria

Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
Histologically-confirmed invasive breast cancer by MSKCC
Status post mastectomy with surgical assessment of axillary nodes
...
Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
Histologically-confirmed invasive breast cancer by MSKCC
Status post mastectomy with surgical assessment of axillary nodes
If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC

Exclusion Criteria

Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.
The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol
Pregnant or breastfeeding.
...
Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.
The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol
Pregnant or breastfeeding.
Prior radiation therapy to the ipsilateral breast/nodes or thorax.
Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Non-Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Description

Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month a...

Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange. Patients who receive neoadjuvant chemotherapy will undergo "rapid expansion" of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment. In these patients, exchange for the permanent implant will occur at the discretion of the treating plastic surgeon (approximately 5-8 months after the end of radiation).

Inclusion Criteria

Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
Histologically-confirmed invasive breast cancer by MSKCC
Status post mastectomy with surgical assessment of axillary nodes
...
Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years
Histologically-confirmed invasive breast cancer by MSKCC
Status post mastectomy with surgical assessment of axillary nodes
If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC

Exclusion Criteria

Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.
The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol
Pregnant or breastfeeding.
...
Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.
The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol
Pregnant or breastfeeding.
Prior radiation therapy to the ipsilateral breast/nodes or thorax.
Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)

Tracking Information

NCT #
NCT02086578
Collaborators
Not Provided
Investigators
  • Principal Investigator: Daphna Gelblum, MD Memorial Sloan Kettering Cancer Center
  • Daphna Gelblum, MD Memorial Sloan Kettering Cancer Center
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