Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01208974
Other study ID # 20090299
Secondary ID SCCC-2009004
Status Recruiting
Phase N/A
First received September 22, 2010
Last updated March 28, 2018
Start date March 16, 2010
Est. completion date April 2021

Study information

Verified date March 2018
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Overall rationale: Prophylactic NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction for patient with ductal carcinoma in-situ or invasive breast cancer will allow better cosmesis and patient's satisfaction:

- The use of NAC-sparing mastectomy followed by postoperative NAC (nipple-areola complex) external beam radiotherapy for selected patient with early stage invasive or in-situ breast cancers will be technically feasible and with acceptable complication rates.

- The cosmetic results after NAC-sparing mastectomy followed by postoperative external beam radiotherapy to the NAC will be better comparable with Skin Sparing Mastectomy.

- The local control rate in the NAC will be more than expected for a NAC sparing mastectomy without postoperative radiotherapy.

- The patient's satisfaction after NAC-sparing mastectomy followed by postoperative NAC external beam radiotherapy will be better than after Skin Sparing Mastectomy.


Description:

Study design: Phase I trial assessing the safety, feasibility and toxicity of prophylactic NAC irradiation after nipple-areola sparing mastectomy and immediate reconstruction in patients with ductal carcinoma in-situ or invasive breast cancer.

Primary objective: To determine the recommended phase I dose of post-operative prophylactic NAC irradiation.

Secondary objectives: To provide extensive descriptive data regarding NAC-sparing surgery with reconstruction, including both surgeon experience and patient evaluation of cosmetic results. Survival and recurrence will be assessed.

Study size: Between 12 and 18 patients will be enrolled in the dose-escalation/deescalation part of this phase I study. An additional expansion cohort of 12 patients will be enrolled at the "potential" recommended phase II dose (RP2D) over an expected accrual period of 2 years.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 2021
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have histologically confirmed in-situ or invasive breast carcinoma.

- Tis, T1, T2 invasive or non-invasive carcinoma of the breast; lesion less than 4 cm.

- Unifocal, multifocal or multicentric breast cancers that can be removed by nipple sparing mastectomy with negative surgical margins.

- No extensive intraductal component or patient with distant metastases.

- Patients must be > 18 years of age.

- No concomitant or history of nipple discharge or skin involvement.

- No prior history of malignancy (less than 5 years prior to study entry), except non-melanomatous skin cancer.

- No prior history of radiation to the chest.

- No collagenous disease (systemic lupus erythematosis, scleroderma, dermatomyositis)No previous non-hormonal therapy including radiation or chemotherapy for current breast cancer.

- No patients with Paget's disease of the nipple.

- No patients with co-existing medical conditions with life expectancy < 2 years.

- No pregnant or lactating women.

- Eastern Cooperative Oncology Group (ECOG) 0 - 2.

- Signed study-specific informed consent form prior to the study entry.

Exclusion Criteria:

- Retroareolar breast cancer lesions within one cm, depth from the skin surface.

- Concomitant or history of nipple discharge or skin involvement.

- Patient with distant metastases.

- Patient with extensive intraductal carcinoma.

- Any previously irradiated ipsilateral breast cancer.

- Patients with Paget's disease of the nipple.

- Patients with collagenous diseases, as systemic lupus erythematosis, scleroderma or dermatomyositis.

- Other malignancy, except nonmelanomatous skin cancer, less than 5 years prior to participation in this study.

- Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.

- Positive surgical margins following nipple sparing mastectomy.

Study Design


Intervention

Procedure:
Nipple-Sparing Mastectomy
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.
Breast Reconstruction
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
Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.
Radiation:
Prophylactic Nipple-Areolar Complex RT
Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.

Locations

Country Name City State
United States University of Miami Sylvester Comprehensive Cancer Center Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of the Recommended Phase II Dose (RP2D) of post-operative prophylactic NAC irradiation. The recommended phase II dose will be the highest irradiation dose level at which <= 1 out of 6 study patients experiences dose-limiting toxicity (DLT). This dose will be the phase dose II of post-operative prophylactic NAC irradiation after NAC-sparing mastectomy with reconstruction in patients with ductal carcinoma in-situ or invasive breast cancer. 3-5 Years
Secondary Surgery Success Rate Surgery success rate, defined as the proportion of patients who had successful NAC sparing surgery with reconstruction divided by the total number of study patients, will be determined. Up to 12 months
Secondary Levels of Cosmetic Outcome in Study Participants - Number Levels of cosmetic results will be assessed by both the physician(s) and the patients at 3, 6 and 12 months, using a 4-category ordinal scale (excellent, good, fair, and poor). Data will be summarized in terms of number of patients in these 4 possible categories at those assessment times separately for assessment by physician and by patient. 3, 6 and 12 months
Secondary Levels of Cosmetic Outcome in Study Participants - Percentage Levels of cosmetic results will be assessed by both the physician(s) and the patients at 3, 6 and 12 months, using a 4-category ordinal scale (excellent, good, fair, and poor). Data will be summarized in terms of percentage of patients in these 4 possible categories at those assessment times separately for assessment by physician and by patient. 3, 6 and 12 months
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. Up to 5 years
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.. Up to 5 years
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. Up to 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT03095352 - A Randomized Phase II Study of Pembrolizumab, an Anti-PD (Programmed Cell Death)-1 Antibody, in Combination With Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients With Chest Wall Disease Phase 2
Active, not recruiting NCT01472094 - Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Recruiting NCT03284957 - Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer Phase 1/Phase 2
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer Phase 2
Recruiting NCT03667716 - COM701 in Subjects With Advanced Solid Tumors Phase 1
Active, not recruiting NCT01857193 - Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Phase 1
Recruiting NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Recruiting NCT03432429 - REI-EXCISE iKnife Study N/A
Active, not recruiting NCT02139358 - Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Recruiting NCT03615573 - Survey Study: Financial Impact of Breast Cancer Treatment
Not yet recruiting NCT03655600 - Acupressure for Pain and Opioid Use Among Breast Cancer Patients N/A
Completed NCT03323333 - Psychosocial Intervention Pilot for Partners in BRCA Testing N/A
Terminated NCT01649258 - Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy Phase 1
Recruiting NCT03473639 - A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy Phase 1
Not yet recruiting NCT03530696 - T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer Phase 2
Not yet recruiting NCT03661892 - Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets Early Phase 1
Withdrawn NCT03285607 - MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer Phase 1
Not yet recruiting NCT03641755 - Olaparib + Sapacitabine in BRCA Mutant Breast Cancer Phase 1/Phase 2