search
Back to results

Pre- Versus Postoperative Accelerated Partial Breast Irradiation (PAPBI-2)

Primary Purpose

Breast Cancer, Cancer of the Breast, Neoplasms, Breast

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
partial breast irradiation
Sponsored by
The Netherlands Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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%

Sites / Locations

  • Institut Curie
  • Institut Gustave-Roussy
  • Antoni van Leeuwenhoek
  • University Medical Center Utrecht (UMCU)
  • Champilamaud Cancer Center
  • University General Hospital Valencia-Erasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

radiotherapy in arm 1

radiotherapy in arm 2

Arm Description

pre-operative accelerated partial breast irradiation

post-operative accelerated partial breast irradiation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

tumor response
pathologic response will be measured in the removed tissue
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

Full Information

First Posted
February 4, 2016
Last Updated
September 27, 2022
Sponsor
The Netherlands Cancer Institute
Collaborators
Institut Curie
search

1. Study Identification

Unique Protocol Identification Number
NCT02913729
Brief Title
Pre- Versus Postoperative Accelerated Partial Breast Irradiation
Acronym
PAPBI-2
Official Title
Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Institut Curie

4. Oversight

Data Monitoring Committee
Yes

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Cancer of the Breast, Neoplasms, Breast
Keywords
breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiotherapy in arm 1
Arm Type
Experimental
Arm Description
pre-operative accelerated partial breast irradiation
Arm Title
radiotherapy in arm 2
Arm Type
Active Comparator
Arm Description
post-operative accelerated partial breast irradiation
Intervention Type
Radiation
Intervention Name(s)
partial breast irradiation
Other Intervention Name(s)
partial breast radiotherapy, accelerated breast irradiation
Intervention Description
irradiation
Primary Outcome Measure Information:
Title
Cosmetic outcome
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
tumor response
Description
pathologic response will be measured in the removed tissue
Time Frame
6 weeks
Title
postoperative complications
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Scholten, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Antoni van Leeuwenhoek
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
Facility Name
University Medical Center Utrecht (UMCU)
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Facility Name
Champilamaud Cancer Center
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
University General Hospital Valencia-Erasa
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data from this clinical trial will be shared with the previous PAPBI clinical trial
Citations:
PubMed Identifier
17577015
Citation
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.
Results Reference
background
PubMed Identifier
8448741
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. doi: 10.1002/1097-0142(19930301)71:53.0.co;2-v.
Results Reference
background
PubMed Identifier
9531371
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. doi: 10.1016/s0360-3016(97)00917-6.
Results Reference
background
PubMed Identifier
12393820
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. doi: 10.1056/NEJMoa022152.
Results Reference
background
PubMed Identifier
1542833
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.
Results Reference
background
PubMed Identifier
17350949
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. doi: 10.1200/JCO.2006.09.7436. Erratum In: J Clin Oncol. 2007 Aug 10;25(23):3561.
Results Reference
background
PubMed Identifier
2144153
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. doi: 10.1016/0277-5379(90)90114-9.
Results Reference
background

Learn more about this trial

Pre- Versus Postoperative Accelerated Partial Breast Irradiation

We'll reach out to this number within 24 hrs