Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| Royal Victoria Regional Health Centre | UNKNOWN |
| AC Camargo Cancer Center | OTHER |
| King Hussein Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (<13% grade >3 toxicity).
Most women affected by breast cancer are treated with breast-conserving surgery to remove the tumour, followed by radiation to reduce the risk of recurrence. Unfortunately, some women will experience recurrence of the cancer in the previously treated breast. These recurrences have historically been treated by removing the whole breast or a second breast-conserving surgery followed by 3 to 5 weeks of radiation. These treatments can negatively impact mental health and quality of life or lead to harmful side effects that could impact the skin, breast, ribs, heart and lungs.
Breast-conserving surgery followed by re-irradiation with partial breast irradiation (rPBI) has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation. By reducing the volume of tissue receiving radiation, rPBI has been associated with less toxicity and improved cosmetic outcomes. For many women with early-stage breast cancer, shorter 1-week (5-fraction) courses of breast radiation (ultra-fractionation) have been found to be equivalent to longer fractionation schedules in the upfront treatment setting. These 1-week schedules are more convenient for patients, with fewer treatments and shorter overall treatment time. The investigators hypothesize that a 1-week ultra-hypofractionated rPBI regimen following breast-conserving surgery (BCS) for local recurrence or new primary breast cancer in the previously irradiated breast (LR) will be associated with acceptable toxicity at 1 year (<13% grade >3 toxicity).
The target population for this study is women with localized recurrent or new primary breast cancer in the previously irradiated breast. This is a prospective single arm phase 2 trial of external beam rPBI using 26Gy in 5 fractions delivered daily over 1-week after a second lumpectomy for LR following prior BCS and adjuvant whole or partial breast irradiation. Using a multi-institutional and international network of comprehensive cancer centers, this study will advance global knowledge of how to optimally treat women with this disease.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rPBI | Experimental | 26Gy in 5 daily fractions over 1-week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rPBI | Radiation | External beam partial breast reirradiation (rPBI) using 26Gy in 5 fractions delivered daily over 1-week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade ≥3 toxicity associated with treatment | TThe primary endpoint, grade ≥3 toxicity associated with treatment will be summarized using frequency and percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up. | During accrual period, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency radiation-associated toxicity (acute) | Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Rodin, MD | Contact | (416) 946-6513 | danielle.rodin@uhn.ca | |
| Anne Koch, MD | Contact | (416) 946-2919 | anne.koch@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Danielle Rodin, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Anne Koch, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207593 | Background | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. | |
| 33812473 | Background | Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| NYU Langone Health | OTHER |
| Centre hospitalier de l'Université de Montréal (CHUM) | OTHER |
| Peter MacCallum Cancer Centre, Australia | OTHER |
| CHU de Quebec-Universite Laval | OTHER |
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
| Virginia Commonwealth University | OTHER |
| AOU Careggi | UNKNOWN |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| Maisonneuve-Rosemont Hospital | OTHER |
| Columbia University | OTHER |
| Lakeridge Health | OTHER |
| London Health Sciences Centre | OTHER |
| ClÃnica IRAM | UNKNOWN |
| University Malaysia Medical Centre | UNKNOWN |
| Aga Khan University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Percentage radiation-associated toxicity (acute) | Radiation-associated toxicities (acute) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Frequency radiation-associated toxicity (late) | Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using frequency with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Percentage radiation-associated toxicity (late) | Radiation-associated toxicities (late) will be graded according to CTCAE v5.0 by physicians. Toxicity associated with treatment will be summarized using percentage with 95% Clopper-Pearson confidence intervals by grade at each scheduled follow up. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Risk of local recurrence (invasive and DCIS) | Cumulative incidence function will be used to estimate local recurrence with death as a competing risk. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Risk of distant recurrence (invasive and DCIS) | Cumulative incidence function will be used to estimate distant recurrence and distance recurrence with death as a competing risk. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Location of local recurrence (in-field) (frequency) | Location of recurrence will be summarized by frequency. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Location of local recurrence (in-field) (percentage) | Location of recurrence will be summarized by percentage. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Location of local recurrence (out-of-field) (frequency) | Location of recurrence will be summarized by frequency. | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Location of local recurrence (out-of-field) (percentage) | Location of recurrence will be summarized by percentage | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Risk of local recurrence after rPBI requiring mastectomy | Cumulative incidence function will be used to estimate local recurrence after rPBI requiring mastectomy with death as a competing risk | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Invasive breast cancer free survival | Kaplan-Meier method will be used to estimate invasive breast cancer free survival | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Overall survival | Kaplan-Meier method will be used to estimate overall survival | 3 months, 1 year, 2 year, 3 years, 4 years and 5 years post rPBI |
| Satisfaction with breasts | Quality of life questionnaire will be used to obtain scores and will summarized using mean and standard deviation at baseline and follow up. Change in score compared to baseline will be summarized using mean and standard deviation, and assessed with paired t-test. Number and proportion of patients with a minimal clinically important difference will be calculated. | Baseline, 1 year, 3 years, and 5 years post rPBI |
| Financial toxicity associated with treatment | Quality of life questionnaire will be used to obtain scores and will summarized using mean and standard deviation at baseline and follow up. Change in score compared to baseline will be summarized using mean and standard deviation, and assessed with paired t-test. Number and proportion of patients with a minimal clinically important difference will be calculated. | Baseline, 3 months, 1 year, and 3 years post rPBI |
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
|
| Virgina Community University Massey Comprehensive Cancer Center | Recruiting | Richmond | Virginia | 23298-0037 | United States |
|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
|
| A.C.Camargo Cancer Center | Recruiting | São Paulo | São Paulo | 105401 | Brazil |
|
| Royal Victoria Regional Health Centre | Recruiting | Barrie | Ontario | L4M 6M2 | Canada |
|
| London Health Science Centre - Verspeeten Family Cancer Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
|
| Lakeridge Health | Recruiting | Oshawa | Ontario | L1G 2B9 | Canada |
|
| Odette Cancer Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G2C4 | Canada |
|
| CHU de Québec-Université Laval | Recruiting | Montreal | Quebec | G1G 5X1 | Canada |
|
| Hôpital Maisonneuve-Rosemont - CIUSSS de l'Est-de-l'Île-de-Montréal | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
|
| Centre hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 3E4 | Canada |
|
| Clinica IRAM | Recruiting | Vitacura | Santiago Metropolitan | 7630370 | Chile |
|
| Tel-Aviv Sourasky Medical Centre | Recruiting | Tel Aviv | Israel |
|
| AOU Careggi - Florence University Hospital | Recruiting | Florence | Italy |
|
| King Hussein Cancer Centre | Recruiting | Amman | Jordan | Jordan |
|
| The Aga Khan University | Recruiting | Nairobi | Kenya |
|
| Universitiy Malaya Medical Centre | Recruiting | Kuala Lumpur | Malaysia |
|
| 25066586 | Background | Fingeret MC, Nipomnick S, Guindani M, Baumann D, Hanasono M, Crosby M. Body image screening for cancer patients undergoing reconstructive surgery. Psychooncology. 2014 Aug;23(8):898-905. doi: 10.1002/pon.3491. Epub 2014 Feb 6. |
| 29959283 | Background | Martei YM, Vanderpuye V, Jones BA. Fear of Mastectomy Associated with Delayed Breast Cancer Presentation Among Ghanaian Women. Oncologist. 2018 Dec;23(12):1446-1452. doi: 10.1634/theoncologist.2017-0409. Epub 2018 Jun 29. |
| 31750868 | Background | Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320. |
| 31436745 | Background | Korzets Y, Lee G, Espin-Garcia O, Purdie T, Koch AC, Hodgson D, Barry A, Fyles A. The Role of Partial Breast Radiation in the Previously Radiated Breast. Am J Clin Oncol. 2019 Dec;42(12):932-936. doi: 10.1097/COC.0000000000000584. |
| 32663119 | Background | Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14. |
| 32580883 | Background | Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28. |
| 30231347 | Background | Barrios CH, Reinert T, Werutsky G. Global Breast Cancer Research: Moving Forward. Am Soc Clin Oncol Educ Book. 2018 May 23;38:441-450. doi: 10.1200/EDBK_209183. |
| 32083950 | Background | Abdel-Razeq H, Mansour A, Jaddan D. Breast Cancer Care in Jordan. JCO Glob Oncol. 2020 Feb;6:260-268. doi: 10.1200/JGO.19.00279. |
| 32926325 | Background | Khader J, Glicksman RM, Mheid S, Mansour A, Giuliani ME, Gospodarowicz M, Almousa A, Abdel-Razeq H, Rodin D. Enhancing International Cancer Organization Collaborations: King Hussein Cancer Center and Princess Margaret Cancer Centre Model for Collaboration. J Cancer Educ. 2022 Jun;37(3):763-769. doi: 10.1007/s13187-020-01878-z. Epub 2020 Sep 14. |
| 33453312 | Background | Rodin D, Tawk B, Mohamad O, Grover S, Moraes FY, Yap ML, Zubizarreta E, Lievens Y. Hypofractionated radiotherapy in the real-world setting: An international ESTRO-GIRO survey. Radiother Oncol. 2021 Apr;157:32-39. doi: 10.1016/j.radonc.2021.01.003. Epub 2021 Jan 14. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided