PAPBI-2: Pre- Versus Postoperative Accelerated Partial Breast Irradiation

• Sponsor: The Netherlands Cancer Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02913729
• Collaborator: Institut Curie (Other)
• Enrollment: 500
• Locations: 6
• Arms: 2
• Anticipated Duration (Months): 118.7
• Patients Per Site: 83.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Most of the local recurrences (LR) found after breast-conserving therapy are within or close to the tumor bed. This pattern of recurrence was confirmed by studies of breast conserving surgery without adjuvant irradiation and by the update of the NSABP B-06 trial. In the EORTC boost trial, however, 29% of all LR were found outside the area of the original tumor. Still, a recent review of Breast Conserving Therapy (BCT) trials showed that the site of local recurrences after BCT was mostly in the tumor bed, with less than 10% of LR elsewhere in the breast. This led to the concept of partial breast irradiation. With accelerated partial breast irradiation (APBI), a limited volume of breast tissue is irradiated, allowing for a higher dose per fraction compared to whole breast irradiation (WBI), which is favorable considering the low alpha/beta ratio, and thus higher sensitivity to high dose per fraction.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Cancer of the Breast; Neoplasms, Breast	Radiation: partial breast irradiation	N/A

Detailed Description

Patients will undergo a partial accelerated breast irradiation pre-or postoperative of 5 x 5.2 Gy

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients
• Actual Study Start Date: Nov 10, 2016
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: radiotherapy in arm 1 pre-operative accelerated partial breast irradiation	Radiation: partial breast irradiation; irradiation; Other Names: partial breast radiotherapy accelerated breast irradiation
Active Comparator: radiotherapy in arm 2 post-operative accelerated partial breast irradiation	Radiation: partial breast irradiation; irradiation; Other Names: partial breast radiotherapy accelerated breast irradiation

Outcome Measures

Primary Outcome Measures

1. Cosmetic outcome [3 years]

   cosmetic effect will be measured by comparing the treated breast with the contralateral breast. Cosmetic effect will be scored in three different ways: by digital photographs, patient's questionnaires and specialist's questionnaires. These data will result in an overall cosmetic outcome, scored as excellent, good, fair or poor.

Secondary Outcome Measures

1. tumor response [6 weeks]

   pathologic response will be measured in the removed tissue

2. postoperative complications [6 weeks]

   The expected acute surgical complication rate is approximately 16%. A stopping rule is set at 15% for complications that require hospitalization (including intravenous antibiotics) and re-surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 51 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female patients ≥ 51 years

• clinical stage tumor-1-2 (≤ 3 cm)

• cN0

• Grade I or grade II (biopsy)

• Histologically proven invasive ductal adenocarcinoma

• Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision to be determined by the participating centre)

• World Health Organization performance status ≤ 2

• Life expectancy ≥ 5 years

• Written informed consent

Exclusion Criteria:

• Distant metastases

• Lobular invasive carcinomas

• Pure Ductal Carcinoma in situ (DCIS) without invasive tumor

• Grade III in biopsy

• Triple negative tumors

• HER2neu positive tumors

• Lymphvascular invasion in biopsy

• TNM pathologic stage N1-3

• pN+ (micro- or macrometastases)

• Multicentric / multifocal disease on mammogram or MRI

• Diffuse calcifications on mammogram (Birads 3, 4 or 5)

• Prior treatment for the protocol tumor (no surgery, no neoadjuvant chemotherapy or neoadjuvant hormonal therapy, no previous radiotherapy)

• Previous contralateral breast cancer

• Other neoplasms in the last 5 years with the exception of:

• Basal cell carcinoma of the skin

• Adequately treated carcinoma in situ of the cervix

• Planned oncoplastic resection with tissue displacement

• No social security affiliation/health insurance

• Participation in another clinical trial that interferes with the locoregional treatment of this protocol

• It is expected that dosimetric constraints cannot be met, ie, lung/heart constraints or if the ratio PTV/ipsilateral breast >30%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Curie	Saint-Cloud		France	92210
2	Institut Gustave-Roussy	Villejuif		France	94805
3	Antoni van Leeuwenhoek	Amsterdam		Netherlands	1066CX
4	University Medical Center Utrecht (UMCU)	Utrecht		Netherlands	3584CX
5	Champilamaud Cancer Center	Lisboa		Portugal	1400-038
6	University General Hospital Valencia-Erasa	Valencia		Spain	46014

Sponsors and Collaborators

• The Netherlands Cancer Institute
• Institut Curie

Investigators

• Principal Investigator: Astrid Scholten, MD, PhD, The Netherlands Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Wárlám-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. Epub 2007 Jun 18.
• Cajucom CC, Tsangaris TN, Nemoto T, Driscoll D, Penetrante RB, Holyoke ED. Results of salvage mastectomy for local recurrence after breast-conserving surgery without radiation therapy. Cancer. 1993 Mar 1;71(5):1774-9.
• Elkhuizen PH, van de Vijver MJ, Hermans J, Zonderland HM, van de Velde CJ, Leer JW. Local recurrence after breast-conserving therapy for invasive breast cancer: high incidence in young patients and association with poor survival. Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):859-67.
• Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.
• Osborne MP, Borgen PI, Wong GY, Rosen PP, McCormick B. Salvage mastectomy for local and regional recurrence after breast-conserving operation and radiation therapy. Surg Gynecol Obstet. 1992 Mar;174(3):189-94.
• Sanders ME, Scroggins T, Ampil FL, Li BD. Accelerated partial breast irradiation in early-stage breast cancer. J Clin Oncol. 2007 Mar 10;25(8):996-1002. Review. Erratum in: J Clin Oncol. 2007 Aug 10;25(23):3561.
• Veronesi U, Volterrani F, Luini A, Saccozzi R, Del Vecchio M, Zucali R, Galimberti V, Rasponi A, Di Re E, Squicciarini P, et al. Quadrantectomy versus lumpectomy for small size breast cancer. Eur J Cancer. 1990;26(6):671-3.

• Responsible Party: The Netherlands Cancer Institute
• ClinicalTrials.gov Identifier: NCT02913729
• Other Study ID Numbers: M15PAP; NL53862.031.15
• First Posted: Sep 26, 2016
• Last Update Posted: Dec 29, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by The Netherlands Cancer Institute: breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 29, 2021