Breast CancerHIPOMAMMLINFNCT04792346
Ten Fraction Adjuvant Hypofractionated Radiotherapy in Node Positive Breast Cancer
An observational study of Breast Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- breast/chest wall radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2015to 2 Mar 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population included breast cancer patients with nodal involvement who underwent conservative surgery or mastectomy, followed by post operative locoregional radiotherapy after conservative surgery or mastectomy.
Who may be able to join
- Patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes.
- pT1-3 disease pN1-2, cT1-3 disease if neoadjuvant chemotherapy , cN + cytologically and/or histologically assessed;
- ECOG Performance status ≤2;
- histologically negative surgical margins
- no distant metastases
- no prior chest radiotherapy
- life expectancy ≥ 5 years
- no prior cancer
Who cannot join
- Non-epithelial breast cancer (sarcoma, lymphoma etc.)
- Metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed
- pT4 neoplasms or inflammatory breast carcinoma
- Distant metastasis
- Concomitant chemotherapy
- history of prior controlateral breast tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: a Feasibility Study of Accelerated Hypofractionated Radiotherapy in Node Positive Breast Cancer Patients Treated With Surgery
Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).
Read the detailed description
The present is a single arm phase II study assessing toxicity levels after 34 Gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery. Both acute (CTCAE v4.0) and late (LENT/SOMA) toxicity were collected. All pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the Harvard. Toxicity was assessed weekly during RT and then at each follow-up examination (1, 3, 6 months and then yearly).
- Conditions
- Breast Cancer
- Being tested
- breast/chest wall radiotherapy
- Keywords
- hypofractionated RT, cosmetic outcome, locoregional treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast/chest wall radiotherapyRadiation
34 Gy/10 fxs/2 wks to the whole breast/chest wall and locoregional lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients undergoing conservative surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
acute toxicity assessment
rate of acute toxicity according to CTCAE v4.0 scale
Measured: 60 months
Secondary outcomes (1)
to evaluate late toxicity
rate of late to according to soma lent scale
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jan 2015
- Primary completion7 Jan 2019
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Giuseppe Sanguineti, Silvia Takanen, Serena Nucciarelli, Francesco Rulli, Maria Papale, Valeria Landoni, Mauro Caterino, Diana Giannarelli, Ilaria Farina, Paola Franzoso
- Responsible party
- Principal investigator, Paola Pinnaro, Regina Elena Cancer Institute
- Investigators
- Paola Pinnaro, Principal investigator, IFO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792346
- Sponsor's protocol ID
- RS618/14(1611)
- Acronym
- HIPOMAMMLINF
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Feasibility Study of Accelerated Hypofractionated Radiotherapy in Node Positive Breast Cancer Patients Treated With Surgery
- ClinicalTrials.gov ID
- NCT04792346
- Acronym / sponsor ID
- HIPOMAMMLINF / RS618/14(1611)
- Conditions
- Breast Cancer
- Keywords
- hypofractionated RT, cosmetic outcome, locoregional treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Giuseppe Sanguineti, Silvia Takanen, Serena Nucciarelli, Francesco Rulli, Maria Papale, Valeria Landoni, Mauro Caterino, Diana Giannarelli, Ilaria Farina, Paola Franzoso
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- 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.
Post-operative loco-regional (LR) hypofractionated radiotherapy (Hypo-RT) is an attractive approach in locally advanced breast cancer (LABC).
Detailed description
The present is a single arm phase II study assessing toxicity levels after 34 Gy/10 fxs/2 wks to the whole breast/chest wall and to the draining lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients who had undergone conservative surgery. Both acute (CTCAE v4.0) and late (LENT/SOMA) toxicity were collected. All pts but those who underwent mastectomy without reconstruction or with temporary expander were also asked to rate their cosmetic outcome according to the Harvard. Toxicity was assessed weekly during RT and then at each follow-up examination (1, 3, 6 months and then yearly).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included breast cancer patients with nodal involvement who underwent conservative surgery or mastectomy, followed by post operative locoregional radiotherapy after conservative surgery or mastectomy.
Key inclusion criteria (8 listed)
- Patients affected by invasive breast cancer who underwent conservative breast surgery or mastectomy and axillary dissection, followed by post operative radiotherapy at the level of the breast/chest wall, and of the supraclavicular, third axillary level +/- internal mammary chain nodes.
- pT1-3 disease pN1-2, cT1-3 disease if neoadjuvant chemotherapy , cN + cytologically and/or histologically assessed;
- ECOG Performance status ≤2;
- histologically negative surgical margins
- no distant metastases
Key exclusion criteria (6 listed)
- Non-epithelial breast cancer (sarcoma, lymphoma etc.)
- Metastases at the level of the internal chain mammary and / or supra-clavicular lymph nodes histologically assessed
- pT4 neoplasms or inflammatory breast carcinoma
- Distant metastasis
- Concomitant chemotherapy
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 |
|---|---|---|
| breast/chest wall radiotherapy34 Gy/10 fxs/2 wks to the whole breast/chest wall and locoregional lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients undergoing conservative surgery | Radiation | – |
Primary outcome
acute toxicity assessment
Time frame: 60 months
rate of acute toxicity according to CTCAE v4.0 scale
1 secondary outcome
to evaluate late toxicity
Time frame: 60 months
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 10 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Paola Pinnaro principal investigator
IFO
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 6 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 10 Mar 2021. 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.
What does the primary outcome measure?
acute toxicity assessment (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2021.