Pre- Versus Postoperative Accelerated Partial Breast Irradiation

NCT02913729 | Terminated DMC

• 2 other identifiers: M15PAPNL53862.031.15
• Study Type: interventional
• Target: 65
• Locations: 4 countries
• Sites: 6

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.

Conditions

Breast Cancer; Cancer of the Breast; Neoplasms, Breast

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• Cosmetic outcome

  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.

  3 years

Secondary Outcomes (2)

• tumor response

  6 weeks

• postoperative complications

  6 weeks

Study Arms (2)

radiotherapy in arm 1

EXPERIMENTAL

pre-operative accelerated partial breast irradiation

Radiation: partial breast irradiation

radiotherapy in arm 2

ACTIVE COMPARATOR

post-operative accelerated partial breast irradiation

Radiation: partial breast irradiation

Interventions

partial breast irradiation RADIATION

irradiation

Also known as: partial breast radiotherapy, accelerated breast irradiation

radiotherapy in arm 1; radiotherapy in arm 2

Eligibility Criteria

• Age: 51 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Institut Curie: collaborator

Study Sites (6)

Institut Curie

Saint-Cloud, 92210, France

Location

Institut Gustave-Roussy

Villejuif, 94805, France

Location

Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

Location

University Medical Center Utrecht (UMCU)

Utrecht, 3584CX, Netherlands

Location

Champilamaud Cancer Center

Lisbon, 1400-038, Portugal

Location

University General Hospital Valencia-Erasa

Valencia, 46014, Spain

Location

Related Publications (7)

• Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-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. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.

  PMID: 17577015 BACKGROUND

• 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. doi: 10.1002/1097-0142(19930301)71:53.0.co;2-v.

  PMID: 8448741 BACKGROUND

• 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. doi: 10.1016/s0360-3016(97)00917-6.

  PMID: 9531371 BACKGROUND

• 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. doi: 10.1056/NEJMoa022152.

  PMID: 12393820 BACKGROUND

• 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.

  PMID: 1542833 BACKGROUND

• 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. doi: 10.1200/JCO.2006.09.7436.

  PMID: 17350949 BACKGROUND

• 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. doi: 10.1016/0277-5379(90)90114-9.

  PMID: 2144153 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Astrid Scholten, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: September 26, 2016
• Study Start: November 10, 2016
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: September 29, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (2); ES (1); NL (2); PT (1)