Breast CancerHYPOPRONENCT01316328
Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery
An observational study of Breast Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase II "single-arm study". The use of a single dose tumor bed is expected to be very effective in terms of tumor control, but it could increase the incidence of radiation induced erythema. Read more about this study
- Who is it for?
- Ages 48 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- May 2010to Dec 2010
- Phase
- Observational
- 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 48 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer (BC) patients following single shot partial breast irradiation(SSPBI) after breast conservative surgery
Who may be able to join
- Age ≥ 48 years old with a life expectancy of at least 5 years
- Post-menopausal status
- Histologically proven, non lobular, adenocarcinoma of the breast
- Primary tumours ≤ 3 cm
- Negative surgical margins (≥ 2 mm)
- Negative sentinel nodes or < 4 positive axillary nodes
- No extra-capsular extension
- No previous radiotherapy
Who cannot join
- multicentric disease
- extended intraductal component (EIC > 25%)
- Paget's disease
- lobular adenocarcinoma
- distant metastases All the above criteria allow to identify patients at low risk of local recurrence.
Trial locations and contacts
1 site in 1 country.
About this study
The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase II "single-arm study". The use of a single dose tumor bed is expected to be very effective in terms of tumor control, but it could increase the incidence of radiation induced erythema. Therefore, the investigators assumed that a decreased DNA repair capability, as well as a reduced detoxification of the damage caused by oxidative stress could explain the increased acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage repair pathways such as GST, XRCC1, XRCC3 and RAD51.
The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high risk, respectively, (groups were identified based on the absence/presence of the above polymorphisms alone or in combination), thus the minimum sample size was 56 patients with α=0.05, 2-tailed test and a power of the study of 80%.
- Conditions
- Breast Cancer
- Keywords
- toxicity after single shot partial breast irradiation (SSPBI)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BC patients after SSPBI | breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316328
- Sponsor's protocol ID
- IFO-84/10
- Acronym
- HYPOPRONE
- Status last verified
- Dec 2010
- First submitted
- 15 Mar 2011
- Last updated
- 16 Mar 2011
- Results posted
- No
Publications
Falvo E, Strigari L, Citro G, Giordano C, Boboc G, Fabretti F, Bruzzaniti V, Bellesi L, Muti P, Blandino G, Pinnaro P. SNPs in DNA repair or oxidative stress genes and late subcutaneous fibrosis in patients following single shot partial breast irradiation. J Exp Clin Cancer Res. 2012 Jan 24;31(1):7. doi: 10.1186/1756-9966-31-7.
PubMed 22272830Pinnaro P, Arcangeli S, Giordano C, Arcangeli G, Impiombato FA, Pinzi V, Iaccarino G, Soriani A, Landoni V, Strigari L. Toxicity and cosmesis outcomes after single fraction partial breast irradiation in early stage breast cancer. Radiat Oncol. 2011 Nov 11;6:155. doi: 10.1186/1748-717X-6-155.
PubMed 22079051Falvo E, Strigari L, Citro G, Giordano C, Arcangeli S, Soriani A, D'Alessio D, Muti P, Blandino G, Sperduti I, Pinnaro P. Dose and polymorphic genes xrcc1, xrcc3, gst play a role in the risk of articledeveloping erythema in breast cancer patients following single shot partial breast irradiation after conservative surgery. BMC Cancer. 2011 Jul 12;11:291. doi: 10.1186/1471-2407-11-291.
PubMed 21749698
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery
- ClinicalTrials.gov ID
- NCT01316328
- Acronym / sponsor ID
- HYPOPRONE / IFO-84/10
- Conditions
- Breast Cancer
- Keywords
- toxicity after single shot partial breast irradiation (SSPBI)
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Mar 2011 (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.
The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase II "single-arm study". The use of a single dose tumor bed is expected to be very effective in terms of tumor control, but it could increase the incidence of radiation induced erythema. Therefore, the investigators assumed that a decreased DNA repair capability, as well as a reduced detoxification of the damage caused by oxidative stress could explain the increased acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage repair pathways such as GST, XRCC1, XRCC3 and RAD51.
The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high risk, respectively, (groups were identified based on the absence/presence of the above polymorphisms alone or in combination), thus the minimum sample size was 56 patients with α=0.05, 2-tailed test and a power of the study of 80%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BC patients after SSPBI | – | –breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery |
Who may qualify
- Ages
- 48 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer (BC) patients following single shot partial breast irradiation(SSPBI) after breast conservative surgery
Key inclusion criteria (8 listed)
- Age ≥ 48 years old with a life expectancy of at least 5 years
- Post-menopausal status
- Histologically proven, non lobular, adenocarcinoma of the breast
- No previous radiotherapy
Key exclusion criteria (5 listed)
- multicentric disease
- extended intraductal component (EIC > 25%)
- Paget's disease
- lobular adenocarcinoma
- distant metastases All the above criteria allow to identify patients at low risk of local recurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- Derived from this study: PubMed 22272830Falvo E, Strigari L, Citro G, Giordano C, Boboc G, Fabretti F, Bruzzaniti V, Bellesi L, Muti P, Blandino G, Pinnaro P. SNPs in DNA repair or oxidative stress genes and late subcutaneous fibrosis in patients following single shot partial breast irradiation. J Exp Clin Cancer Res. 2012 Jan 24;31(1):7. doi: 10.1186/1756-9966-31-7.
- Derived from this study: PubMed 22079051Pinnaro P, Arcangeli S, Giordano C, Arcangeli G, Impiombato FA, Pinzi V, Iaccarino G, Soriani A, Landoni V, Strigari L. Toxicity and cosmesis outcomes after single fraction partial breast irradiation in early stage breast cancer. Radiat Oncol. 2011 Nov 11;6:155. doi: 10.1186/1748-717X-6-155.
- Derived from this study: PubMed 21749698Falvo E, Strigari L, Citro G, Giordano C, Arcangeli S, Soriani A, D'Alessio D, Muti P, Blandino G, Sperduti I, Pinnaro P. Dose and polymorphic genes xrcc1, xrcc3, gst play a role in the risk of articledeveloping erythema in breast cancer patients following single shot partial breast irradiation after conservative surgery. BMC Cancer. 2011 Jul 12;11:291. doi: 10.1186/1471-2407-11-291.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316328, which also lists 3 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 16 Mar 2011.