Breast CancerPAPBI-2NCT02913729
Pre- Versus Postoperative Accelerated Partial Breast Irradiation
A study testing partial breast irradiation in people with Breast Cancer and Cancer of the Breast, run by The Netherlands Cancer Institute at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 51 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer of the Breast, Neoplasms, Breast
- What is being tested?
- partial breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 10 Nov 2016to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- World Health Organization performance status ≤ 2
- Life expectancy ≥ 5 years
- Written informed consent
Who cannot join
- Distant metastases
- Lobular invasive carcinomas
- Pure Ductal Carcinoma in situ (DCIS) without invasive tumor
- Grade III in biopsy
- Triple negative tumors
- HER2neu positive tumors
Show all 20Show fewer
- 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%
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France2 sites
Institut Curie
Saint-Cloud, 92210
Institut Gustave-Roussy
Villejuif, 94805
Netherlands2 sites
Antoni van Leeuwenhoek
Amsterdam, 1066CX
University Medical Center Utrecht (UMCU)
Utrecht, 3584CX
About this study
Official title: Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients
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.
Read the 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
- Being tested
- partial breast irradiation
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial breast irradiationRadiation
Also called partial breast radiotherapy, accelerated breast irradiation
irradiation
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy in arm 1 | Experimental | pre-operative accelerated partial breast irradiation Receives: Radiation: partial breast irradiation |
| radiotherapy in arm 2 | Active comparator | post-operative accelerated partial breast irradiation Receives: Radiation: partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
tumor response
pathologic response will be measured in the removed tissue
Measured: 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start10 Nov 2016
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Curie
- Responsible party
- Sponsor
- Investigators
- Astrid Scholten, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913729
- Sponsor's protocol ID
- M15PAP
- Other IDs
- NL53862.031.15
- Acronym
- PAPBI-2
- Status last verified
- Dec 2021
- First submitted
- 4 Feb 2016
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: data from this clinical trial will be shared with the previous PAPBI clinical trial
Publications
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.
PubMed 17577015Cajucom 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.
PubMed 8448741Elkhuizen 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.
PubMed 9531371Fisher 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.
PubMed 12393820Osborne 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.
PubMed 1542833Sanders 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.
PubMed 17350949Veronesi 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.
PubMed 2144153
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- Versus Postoperative Accelerated Partial Breast Irradiation in Early Stage Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02913729
- Acronym / sponsor ID
- PAPBI-2 / M15PAP
- Conditions
- Breast Cancer, Cancer of the Breast, Neoplasms, Breast
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual
- Enrolment
- 65 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Institut Curie
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy in arm 1 | Experimental | Radiation: partial breast irradiationpre-operative accelerated partial breast irradiation |
| radiotherapy in arm 2 | Active comparator | Radiation: partial breast irradiationpost-operative accelerated partial breast irradiation |
Who may qualify
- Ages
- 51 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients ≥ 51 years
- clinical stage tumor-1-2 (≤ 3 cm)
- cN0
- Grade I or grade II (biopsy)
- Histologically proven invasive ductal adenocarcinoma
Key exclusion criteria (20 listed)
- Distant metastases
- Lobular invasive carcinomas
- Pure Ductal Carcinoma in situ (DCIS) without invasive tumor
- Grade III in biopsy
- Triple negative tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| partial breast irradiationAlso: partial breast radiotherapy, accelerated breast irradiationirradiation | Radiation | radiotherapy in arm 1, radiotherapy in arm 2 |
Primary outcome
Cosmetic outcome
Time frame: 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.
2 secondary outcomes
tumor response
Time frame: 6 weeks
postoperative complications
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 17577015Bartelink 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.
- Background: PubMed 8448741Cajucom 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.
- Background: PubMed 9531371Elkhuizen 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.
- Background: PubMed 12393820Fisher 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.
- Background: PubMed 1542833Osborne 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.
- Background: PubMed 17350949Sanders 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.
- Background: PubMed 2144153Veronesi 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.
- Individual participant dataSharing planned: Yes. data from this clinical trial will be shared with the previous PAPBI clinical trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Astrid Scholten, MD, PhD principal investigator
The Netherlands Cancer Institute
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial breast irradiation in people with Breast Cancer and Cancer of the Breast, run by The Netherlands Cancer Institute at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Netherlands, Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmetic outcome (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913729, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.