Pre- Versus Postoperative Accelerated Partial Breast Irradiation

NCT ID: NCT02913729

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-10
• Study Completion Date: 2022-02-28

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.

Detailed Description

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

Conditions

Breast Cancer; Cancer of the Breast; Neoplasms, Breast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

radiotherapy in arm 1

pre-operative accelerated partial breast irradiation

Group Type: EXPERIMENTAL

partial breast irradiation

Intervention Type: RADIATION

irradiation

radiotherapy in arm 2

post-operative accelerated partial breast irradiation

Group Type: ACTIVE_COMPARATOR

partial breast irradiation

Intervention Type: RADIATION

irradiation

Interventions

partial breast irradiation

irradiation

Intervention Type: RADIATION

Other Intervention Names

partial breast radiotherapy; accelerated breast irradiation

Eligibility Criteria

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%

• Minimum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Astrid Scholten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

Institut Curie

Saint-Cloud, , France

Institut Gustave-Roussy

Villejuif, , France

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

University Medical Center Utrecht (UMCU)

Utrecht, , Netherlands

Champilamaud Cancer Center

Lisbon, , Portugal

University General Hospital Valencia-Erasa

Valencia, , Spain

Countries

France; Netherlands; Portugal; Spain

References

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.

Reference Type: BACKGROUND

PMID: 17577015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8448741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9531371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12393820 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1542833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17350949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2144153 (View on PubMed)

Other Identifiers

NL53862.031.15

Identifier Type: OTHER

Identifier Source: secondary_id

M15PAP

Identifier Type: -

Identifier Source: org_study_id