삼중음성유방암 관리에서 유전학적 유도 방사선 요법
삼중음성유방암 관리에서 유전체 유도 방사선량 개인화에 대한 2상 연구
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Kamran Ahmed, MD
- 전화번호: 813-745-3320
- 이메일: Kamran.Ahmed@moffitt.org
연구 연락처 백업
- 이름: Robin Dowell
- 전화번호: 813-745-0393
- 이메일: Robin.Dowell@moffitt.org
연구 장소
-
-
Florida
-
Clearwater, Florida, 미국, 33756
- 모병
- Morton Plant Hospital - Baycare Health System
-
연락하다:
- Ken Tardif
- 전화번호: 727-462-3921
- 이메일: Ken.Tardif@baycare.org
-
수석 연구원:
- Ronica H. Nanda, MD
-
Tampa, Florida, 미국, 33612
- 모병
- Moffitt Cancer Center
-
수석 연구원:
- Kamran Ahmed, MD
-
수석 연구원:
- Ronica H Nanda, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants should have undergone breast conservation therapy with a lumpectomy and axillary evaluation to consist of a sentinel node biopsy or axillary dissection
- Confirmation of Triple Negative (TN) breast cancer by tissue biopsy
- Adequate tissue to calculate RSI
- To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined by the ASCO / CAP Guidelines
- To fulfill the requirement of hormone receptor (HR)- disease, a breast cancer must express (<10%), by immunohistochemistry (IHC), the hormone receptors (estrogen receptor [ER] and progesterone receptor [PR]) as defined in the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) Guidelines
- Life expectancy >16 weeks
- KPS ≥ 70
- Age ≥ 18 years
- Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
- There is no limit on prior systemic therapies
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
- Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before study enrollment
Exclusion Criteria:
- Major surgery or significant traumatic injury that has not been recovered from 14 days before study initiation
- Women who are pregnant or breastfeeding
- Positive surgical margins
- History of allergy or hypersensitivity to any of the study drugs or study drug components
- Metastatic breast cancer
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Radiosensitivity Index optimized
Participants will be assigned to optimized arm based on their RSI score. Participants will receive whole breast radiation therapy with or without regional lymph node irradiation as appropriate with or without a boost to the lumpectomy cavity. |
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity. Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity. |
|
활성 비교기: Radiosensitivity Index not optimized
Participants will receive standard of care whole breast radiation therapy with or without regional lymph node irradiation as appropriate with a boost to the lumpectomy cavity. |
Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with or without a boost of 10 Gy in 5 fractions to the cavity. Participants will receive treatment 5 days per week, in once daily fractions. The total dose will be 50 Gy in 25 fractions or 42.56 Gy in 16 fractions with a boost of 10 Gy in 5 fractions to the cavity. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Local Control
기간: At 3 Years
|
Local control will be defined as lack of progression in the ipsilateral breast as documented by response assessment imaging |
At 3 Years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: Up to 5 Years
|
OS will be measured from the date of study initiation to the date of death due to any cause. |
Up to 5 Years
|
|
Progression Free Survival (PFS)
기간: Up to 5 years
|
PFS is measured from the date of first treatment to the date of first observation of PD or death due to any cause. |
Up to 5 years
|
|
Distant Control
기간: Up to 5 Years
|
Distant control will be defined by lack of progression outside the irradiated treatment field |
Up to 5 Years
|
|
Quality of Life following Genomically Guided Dose Personalization
기간: Up to 5 Years
|
Quality of life (QOL) will be assessed through the completion of the Functional Assessment of Cancer Therapy for Breast Cancer questionnaire (FACT-B). This quality of life questionnaire contains questions from the FACT-General (G) questionnaire in the domains of physical, social/family, emotional, and functional well-being as well as additional questions pertaining to patients with breast cancer. The questionnaire will be completed at screening, during protocol therapy and at follow-up visits |
Up to 5 Years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Kamran Ahmed, MD, Moffitt Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MCC-21757
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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