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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2009004 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center |
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The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 MTD NAC RT | Experimental | Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows:
Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT). Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipple-Sparing Mastectomy | Procedure | Subcutaneous Mastectomy (SCM) to be performed, preserving the nipple and areola complex, after a frozen section of the tissue underneath the nipple-areola complex is sampled and found to be negative for tumor. Performed during Week 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation. | The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0. | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Outcome | Cosmetic Outcome will be reported as the number of participants in each of the 4 cosmetic outcome category ordinal scale. The 4 cosmetic outcome category scales are excellent, good, fair and poor. Both physician and patient's evaluation will be reported. | 12 months |
| Disease-Free Survival Rate in Study Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristiane Takita, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
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Participants undergo NAC-Sparing Mastectomy, and then receive prophylactic radiation therapy according to a dose-escalation/de-escalation design, the first cohort of 2 to 6 patients starting at dose level II (10 Fractions of 2.5 Gy). If 2 or more participants experience dose-limiting toxicities at the starting dose level (dose level II), then de-escalation occurs to dose level I (10 Fractions of 2.0 Gy) for the next cohort of 2 to 6 participants. No participants were assigned to dose level I.
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| ID | Title | Description |
|---|---|---|
| FG000 | NAC-Sparing Mastectomy | Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4. All participants complete this surgery and post-mastectomy period before being assigned to a dosing arm for prophylactic radiation therapy. |
| FG001 | Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy (Starting Dose) | The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy. |
| FG002 | Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy | The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II. |
| FG003 | Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy | The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NAC-Sparing Mastectomy |
| |||||||||||||
| Post-Mastectomy Period (Weeks 1 to 4) |
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| Prophylactic NAC RT (Weeks 5 to 8) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 MTD NAC RT | Participants will undergo a Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, if indicated, on Week 1. Anytime between Weeks 5-8, participants will undergo a dose-escalation/de-escalation of prophylactic NAC radiation treatment (RT) twice daily (minimum of 4 hours apart) for 5 days. Dose escalation/de-escalation design are as follows:
Participants will be treated between cohorts of 2-6 patients per dose level starting at dose level II. Dose escalation stops when 2 out of 2-6 participants encounter Dose Limiting Toxicities (DLT). Standard of care chemotherapy, at treating physician's discretion, can be initiated 2 weeks after RT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Prophylactic NAC Irradiation. | The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0. | A total of 18 participants at dose-escalating study design (6 participants at each dose level - Levels II, III and IV) who received prophylactic NAC RT after nipple-sparing mastectomy were evaluated to assess the MTD/Recommended Phase II dose. | Posted | Number | Gy (grays) | Up to 13 weeks |
|
Up to 8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAC-Sparing Mastectomy | Participants who completed Nipple-Areolar Complex (NAC)-sparing mastectomy with immediate reconstruction and axillary surgery, and intra-/post-operative period from weeks 1 to 4. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery/Intra-Operative Injury | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristiane Takita MD | University of Miami | 305-243-4337 | ctakita@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2017 | Oct 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D044584 | Carcinoma, Ductal |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015414 | Mastectomy, Subcutaneous |
| D016462 | Mammaplasty |
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
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Phase 1 dose-escalation/de-escalation.
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|
| Breast Reconstruction | Procedure | Immediate reconstruction of the breast will be performed (after Nipple-Sparing Mastectomy) by the plastic surgeon, type depend on surgeon's discretion and patient's desire. Performed during Week 1. |
|
| Axillary Surgery | Procedure | Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion. |
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| Prophylactic Nipple-Areolar Complex RT | Radiation | Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8. |
|
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Disease-free survival rate in study participants will be assessed. Disease-free survival is defined from the date of surgery until the date of documented recurrence (local or distant) or breast cancer-related death, whichever occurs first. Patients who die without documentation of recurrence will be considered to have had disease recurrence at the time of death, unless there is documented evidence that no recurrence occurred before death. |
| Up to 5 years |
| Overall Survival Rate in Study Participants | Overall Survival rate in study participants will be assessed. Overall survival is the defined from the date of surgery until the date of death due to any cause. In the absence of death, follow-up time will be censored by the date of last contact.. | Up to 5 years |
| Recurrence Rate in Study Participants | Rate of disease recurrence in study participants. The definition of local recurrence is histologic evidence of recurrent carcinoma, either invasive or non-invasive in the nipple-areola complex in the ipsilateral breast. Clinical evidence of carcinoma by physical exam and/or mammograms/MRI will not be evidence of local recurrence until biopsy proof. | Up to 5 years |
| COMPLETED |
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| NOT COMPLETED |
|
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| Cohort 1: Starting Dose |
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| Cohort 2: 1st Dose Escalation |
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| Cohort 3: 2nd Dose Escalation |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants who received NAC RT after nipple-sparing mastectomy at the following dose levels:
|
|
| Secondary | Cosmetic Outcome | Cosmetic Outcome will be reported as the number of participants in each of the 4 cosmetic outcome category ordinal scale. The 4 cosmetic outcome category scales are excellent, good, fair and poor. Both physician and patient's evaluation will be reported. | Not Posted | May 2027 | 12 months | Participants |
| Secondary | Disease-Free Survival Rate in Study Participants | Disease-free survival rate in study participants will be assessed. Disease-free survival is defined from the date of surgery until the date of documented recurrence (local or distant) or breast cancer-related death, whichever occurs first. Patients who die without documentation of recurrence will be considered to have had disease recurrence at the time of death, unless there is documented evidence that no recurrence occurred before death. | Not Posted | May 2027 | Up to 5 years | Participants |
| Secondary | Overall Survival Rate in Study Participants | Overall Survival rate in study participants will be assessed. Overall survival is the defined from the date of surgery until the date of death due to any cause. In the absence of death, follow-up time will be censored by the date of last contact.. | Not Posted | May 2027 | Up to 5 years | Participants |
| Secondary | Recurrence Rate in Study Participants | Rate of disease recurrence in study participants. The definition of local recurrence is histologic evidence of recurrent carcinoma, either invasive or non-invasive in the nipple-areola complex in the ipsilateral breast. Clinical evidence of carcinoma by physical exam and/or mammograms/MRI will not be evidence of local recurrence until biopsy proof. | Not Posted | May 2027 | Up to 5 years | Participants |
| 0 |
| 21 |
| 1 |
| 21 |
| 12 |
| 21 |
| EG001 | Prophylactic NAC RT - Dose Level II - 10 Fractions of 2.5 Gy | The first 6 participants that had received the starting dose of NAC Prophylactic Radiation Therapy (RT) at Dose Level II - 10 fractions of 2.5 Gy for a total of 25 Gy after completing NAC-Sparing mastectomy. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Prophylactic NAC RT - Dose Level III - 10 Fractions of 3.0 Gy | The second group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level III - 10 fractions of 3.0 Gy for a total of 30 Gy after completing NAC-Sparing mastectomy, and after the first 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level II. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Prophylactic NAC RT - Dose Level IV - 10 Fractions of 3.5 Gy | The third group of 6 participants that had received Prophylactic NAC Radiation Therapy (RT) at Dose Level IV - 10 fractions of 3.5 Gy for a total of 35 Gy after completing NAC-Sparing mastectomy, and after the second 6 participants reported 0 dose-limiting toxicities (DLTs) at Dose Level III. | 0 | 6 | 0 | 6 | 6 | 6 |
| Pain - Other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Back Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Breast Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Chest Wall Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Dermatitis: Radiation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Small area of scab on the left nipple | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Skin sloughing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nipple congestion | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nipple eschar | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Occasional tightness in the axillary redion | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Crusting on incisions | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Burning sensation along the incisions | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right nipple with slight bulla | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin necrosis (on the side of right prophylactic reconstructed breast) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Left breast skin necrosis cancer side | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Edema: trunk/genital | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Hematoma | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Myalgia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Breast nipple/areolar deformity | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Occasional pain in the axillary region | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain in extremity | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain of skin | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Infection with unknown ANC |
|
| Seroma | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Infection with normal ANC or Grade 1 or 2 neutrophils |
|
| Telangiectasia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vasculitis | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Bruising (in absence of Grade 3 or 4 thrombocytopenia) |
|
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D019651 |
| Plastic Surgery Procedures |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |