Cancer of BreastPhase 2NCT02375048
Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: WBI Versus APBI
A Phase 2 study testing Hypofractionated WBI and Accelerated Partial Breast Irradiation in people with Cancer of Breast, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women only
- Conditions the study is for
- Cancer of Breast
- What is being tested?
- Hypofractionated WBI and Accelerated Partial Breast Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2015to 1 Feb 2018
- Phase
- Phase 2
- 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 55 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55< Age <70
- Tumor size ≤ 2 cm
- pN0 (SN biopsy or ALND)
- ER/PgR positive
- Margins > 5 mm (either at initial surgery or at re-excision)
- Clips placed in the surgical bed (minimum of 4 clips)
Show all 11Show fewer
- Unicentric only
- No lymphovascular invasion
- Any grade
- No extensive intraductal component (>25%)
- Written informed consent
Who cannot join
- Prior thoracic radiation therapy
- Oncoplastic surgery / No clips in the surgical bed
- Multicentric cancer
- Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.
Read the detailed description
Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.
- Conditions
- Cancer of Breast
- Being tested
- Hypofractionated WBI, Accelerated Partial Breast Irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated WBIRadiation
Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
Accelerated Partial Breast IrradiationRadiation
APBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated WBI | Active comparator | Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA). Receives: Radiation: Hypofractionated WBI |
| Accelerated Partial Breast Irradiation | Experimental | Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA). Receives: Radiation: Accelerated Partial Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity will be measured with CTCAE v.4.0
Measured: ten years
Cosmesis will be measured with Harvard scale
Measured: ten years
Secondary outcomes (4)
Rate of Local Control
Measured: ten years
Disease Free Survival
Measured: ten years
Overall Survival
Measured: ten years
Quality of Life Questionnaire
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start19 Jan 2015
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Why it stopped: number of enrollments not reached in the estimated time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of BreastStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Marta Scorsetti, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375048
- Sponsor's protocol ID
- 1288
- Status last verified
- Oct 2018
- First submitted
- 13 Feb 2015
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
- ClinicalTrials.gov ID
- NCT02375048
- Acronym / sponsor ID
- 1288
- Conditions
- Cancer of Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: number of enrollments not reached in the estimated time
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 19 Jan 2015 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 2 Mar 2015 (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.
Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.
Detailed description
Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated WBI | Active comparator | Radiation: Hypofractionated WBIPatients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA). |
| Accelerated Partial Breast Irradiation | Experimental | Radiation: Accelerated Partial Breast IrradiationPatients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA). |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 55< Age <70
- Tumor size ≤ 2 cm
- pN0 (SN biopsy or ALND)
- ER/PgR positive
- Margins > 5 mm (either at initial surgery or at re-excision)
Key exclusion criteria (4 listed)
- Prior thoracic radiation therapy
- Oncoplastic surgery / No clips in the surgical bed
- Multicentric cancer
- Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
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 |
|---|---|---|
| Hypofractionated WBIDose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up. | Radiation | Hypofractionated WBI |
| Accelerated Partial Breast IrradiationAPBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment. | Radiation | Accelerated Partial Breast Irradiation |
Primary outcome
Toxicity will be measured with CTCAE v.4.0
Time frame: ten years
Cosmesis will be measured with Harvard scale
Time frame: ten years
4 secondary outcomes
Rate of Local Control
Time frame: ten years
Disease Free Survival
Time frame: ten years
Overall Survival
Time frame: ten years
Quality of Life Questionnaire
Time frame: ten years
Results and safety
The study was stopped early (reason given: number of enrollments not reached in the estimated time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
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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.
Marta Scorsetti, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated WBI and Accelerated Partial Breast Irradiation in people with Cancer of Breast, run by Istituto Clinico Humanitas 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 11 inclusion and 4 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 24 Oct 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: number of enrollments not reached in the estimated time). 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?
Toxicity will be measured with CTCAE v.4.0 (time frame: ten years). The study lists 2 primary outcomes in all. 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 24 Oct 2018.