Pre- Versus Postoperative Accelerated Partial Breast Irradiation

Breast Cancer Clinical Trial

— PAPBI-2  

Official title:

Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02913729
• Other study ID #: M15PAP
• Secondary ID: NL53862.031.15
• Status: Terminated
• Phase: N/A
• Start date: November 10, 2016
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2021
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 51 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of the Breast
• Neoplasms, Breast

Intervention

Radiation:
• partial breast irradiation
irradiation

Locations

Country	Name	City	State
France	Institut Curie	Saint-Cloud
France	Institut Gustave-Roussy	Villejuif
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	University Medical Center Utrecht (UMCU)	Utrecht
Portugal	Champilamaud Cancer Center	Lisboa
Spain	University General Hospital Valencia-Erasa	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Institut Curie

Countries where clinical trial is conducted

France,  Netherlands,  Portugal,  Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	tumor response	pathologic response will be measured in the removed tissue	6 weeks
Secondary	postoperative complications	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	6 weeks