Breast CancerPhase 2ABLATIVE-2NCT03863301
MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer
A Phase 2 study testing MR-guided single dose preoperative PBI in people with Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MR-guided single dose preoperative PBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Mar 2019to Nov 2031
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO performance scale ≤2.
- Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with unifocal cT1-2(maximum 3 cm)N0 breast cancer on mammography, ultrasound and MRI.
- Patients with an indication for chemotherapy or immunotherapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
- Tumor size as assessed on MRI.
- On tumor biopsy:
- Bloom-Richardson grade 1 or 2.
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- Non-lobular invasive histological type carcinoma.
- LCIS or (non-extensive) DCIS is accepted.
- ER positive tumor receptor.
- HER2 negative tumor.
- Tumor-negative sentinel node.
- Adequate communication and understanding skills of the Dutch language.
Who cannot join
- Legal incapacity.
- BRCA1, BRCA2 or CHEK2 gene mutation.
- Previous history of breast cancer or DCIS.
- Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
- Collagen synthesis disease.
- Signs of extensive DCIS component on histological biopsy or imaging.
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- Invasive lobular carcinoma.
- MRI absolute contraindications as defined by the Department of Radiology.
- Nodal involvement with cytological or histological confirmation.
- Indication for treatment with (neo-)adjuvant chemotherapy.
- Non-feasible dosimetric RT plan.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated.
Read the detailed description
In this multi-center single arm interventional cohort study 70 patients will be treated with single dose preoperative partial breast irradiation (PBI). Breast conserving surgery will be performed 12 months following PBI to assess pathologic response. Response monitoring following PBI includes MRI (3T and 7T), liquid biopsies and biopsy of the irradiated tumor.
Results from this trial can change the current treatment of patients with early stage breast cancer. The single dose PBI can be of benefit for all patients who are suitable for postoperative PBI according to current guidelines. If pathologic complete response can be accurately predicted by (one of) the abovementioned response monitoring modalities, the need for surgery will become disputable. Moreover, in patients without expected pathologic complete response, the burden of radiotherapy can be minimized from 3-4.5 weeks of radiotherapy to a single dose of radiotherapy.
- Conditions
- Breast Cancer
- Being tested
- MR-guided single dose preoperative PBI
- Keywords
- Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided single dose preoperative PBIRadiation
A single dose of 20Gy to the gross tumor volume (GTV) is prescribed, to the clinical target volume (GTV + 20mm margin) 15Gy is prescribed.
| Study group | Role | What they receive |
|---|---|---|
| MR-guided single dose preoperative PBI | Experimental | Not described Receives: Radiation: MR-guided single dose preoperative PBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
pCR is assessed 6 or 12 months following single dose radiotherapy. Patients will undergo breast-conserving surgery.
Measured: up to 12 months
Secondary outcomes (15)
Radiologic response on MRI
A 3T MRI will be made 1 week, 3 months, 6 months, 9 months and 12 months following radiotherapy. This will be correlated to the pathologic response.
Measured: up to 12 months
Biopsy of irradiated tumor
A biopsy of the irradiated tumor will be taken before surgery, this will be evaluated for presence of tumor cells. This will be correlated to the pathologic response.
Measured: up to 12 months
Treatment-induced toxicity
Radiotherapy- and surgery-induced toxicity will be assessed up to 10 years following radiotherapy according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Measured: 10 years
Patient reported outcomes - quality of life
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cancer-30 (C30), a cancer specific questionnaire on quality of life.
The C30 consists of the global quality of life (scale 0-100, higher scores indicate higher quality of life), 5 functional domains (physical, role, emotional, cognitive and social functioning, scale 0-100, higher scores indicate better functioning) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties, scale 0-100, higher scores indicate more symptoms). No total score is calculated.
Measured: 10 years
Patient reported outcomes - quality of life
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Breast-23 (BR23), a breast cancer specific questionnaire on quality of life.
The BR23 consists of 4 functional domains (body image, sexual functioning, sexual enjoyment and future perspectives, scale 0-100, higher scores indicate better functioning) and 4 symptom domains (systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss, scale 0-100, higher scores indicate more symptoms) . No total score is calculated.
Measured: 10 years
Patient reported outcomes - anxiety and depression
Anxiety and depression (Hospital Anxiety and Depression Scale): The scales ranges from 0 to 21 for both domains anxiety and depression separately. Higher scores indicate more complaints of anxiety or depression. No total score is calculated.
Measured: 10 years
Patient reported outcomes - fatigue
Fatigue (Multidimensional Fatigue Index). Five dimensions are present: General fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. All dimensions range from 4-20, higher scores indicate more symptoms of fatigue on the specific dimension. No total score is calculated.
Measured: 10 years
Patient reported outcomes - work ability
Work ability (Work Ability Index). Seven dimensions are present: current work ability compared to best work ability (scale 0-10), work ability compared to demands of work (scale 2-10), current number of disease (scale 1-7),loss of work ability due to disease (scale 1-6), absenteeism past 12 months (scale 1-5), prognosis work ability in 2 years (scale 1-7), vitality (scale 1-4). A total score of work ability is calculated as the sum of all dimension (scale 7-49). In all dimension higher scores indicate better work ability.
Measured: 10 years
Patient reported outcomes - frailty
Frailty (Groningen Frailty Indicator), one dimension (scale 0-15), higher scores indicate higher level of frailty.
Measured: 10 years
Patient reported outcomes - satisfaction with cosmesis
Satisfaction with cosmesis (questionnaire by Sneeuw et al. and BREAST-Q)). The questionnaire by Sneeuw et al. consists of seven questions, no total score is calculated. These questions are about difference between the treated and untreated breast in terms of size, shape, skin color, firmness and overall cosmesis (scale: no difference, small difference, moderate difference, large difference), visibility of the surgical scar (scale: not distracting, little distracting, quite distracting, very distracting) and satisfaction with the appearance of the treated breast (scale: very satisfied, satisfied, not unsatisfied, unsatisfied, very unsatisfied). No total score is calculated.
From the BREAST-Q questionnaire only the postoperative domain of satisfaction with the breasts is used (scale 0-100), higher scores indicate more satisfaction.
Measured: 10 years
Local, regional and distant relapse rate
Recurrences up to 10 years following radiotherapy will be evaluated.
Measured: 10 years
Disease free survival
Disease free survival will be evaluated as the interval between treatment and first date of recurrence of disease.
Measured: 10 years
Overall survival
Overall survival will be evaluated as interval between treatment and death.
Measured: 10 years
Tumor infiltrating lymphocytes
The presence of tumor infiltrating lymphocytes in the tumor will be assessed at baseline (using the diagnostic biopsy) and following treatment (using the surgical resection). This will be correlated to the pathologic response.
Measured: up to 12 months
Circulating tumor DNA
Patients will be evaluated for the presence of circulating tumor DNA at baseline and following radiotherapy. This will be correlated to the pathologic response.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start4 Mar 2019 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2031 (estimated)
Why it stopped: no participants enrolled
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.
- More trials run by UMC UtrechtThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm interventional cohort study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HJGD van den Bongard, UMC Utrecht
- Investigators
- Desiree van den Bongard, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863301
- Sponsor's protocol ID
- NL63209 041 18
- Acronym
- ABLATIVE-2
- Status last verified
- Feb 2021
- First submitted
- 15 Jan 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer
- ClinicalTrials.gov ID
- NCT03863301
- Acronym / sponsor ID
- ABLATIVE-2 / NL63209 041 18
- Conditions
- Breast Cancer
- Keywords
- Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 4 Mar 2019 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 5 Mar 2019 (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.
This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated.
Detailed description
In this multi-center single arm interventional cohort study 70 patients will be treated with single dose preoperative partial breast irradiation (PBI). Breast conserving surgery will be performed 12 months following PBI to assess pathologic response. Response monitoring following PBI includes MRI (3T and 7T), liquid biopsies and biopsy of the irradiated tumor.
Results from this trial can change the current treatment of patients with early stage breast cancer. The single dose PBI can be of benefit for all patients who are suitable for postoperative PBI according to current guidelines. If pathologic complete response can be accurately predicted by (one of) the abovementioned response monitoring modalities, the need for surgery will become disputable. Moreover, in patients without expected pathologic complete response, the burden of radiotherapy can be minimized from 3-4.5 weeks of radiotherapy to a single dose of radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm interventional cohort study
| Arm | Type | Receives |
|---|---|---|
| MR-guided single dose preoperative PBI | Experimental | Radiation: MR-guided single dose preoperative PBI |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- WHO performance scale ≤2.
- Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with unifocal cT1-2(maximum 3 cm)N0 breast cancer on mammography, ultrasound and MRI.
- On tumor biopsy:
- Tumor-negative sentinel node.
- Adequate communication and understanding skills of the Dutch language.
Key exclusion criteria (11 listed)
- Legal incapacity.
- BRCA1, BRCA2 or CHEK2 gene mutation.
- Previous history of breast cancer or DCIS.
- Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
- Collagen synthesis disease.
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 |
|---|---|---|
| MR-guided single dose preoperative PBIA single dose of 20Gy to the gross tumor volume (GTV) is prescribed, to the clinical target volume (GTV + 20mm margin) 15Gy is prescribed. | Radiation | MR-guided single dose preoperative PBI |
Primary outcome
Pathologic complete response (pCR)
Time frame: up to 12 months
pCR is assessed 6 or 12 months following single dose radiotherapy. Patients will undergo breast-conserving surgery.
15 secondary outcomes
Radiologic response on MRI
Time frame: up to 12 months
Biopsy of irradiated tumor
Time frame: up to 12 months
Treatment-induced toxicity
Time frame: 10 years
Patient reported outcomes - quality of life
Time frame: 10 years
Patient reported outcomes - quality of life
Time frame: 10 years
Patient reported outcomes - anxiety and depression
Time frame: 10 years
Patient reported outcomes - fatigue
Time frame: 10 years
Patient reported outcomes - work ability
Time frame: 10 years
Patient reported outcomes - frailty
Time frame: 10 years
Patient reported outcomes - satisfaction with cosmesis
Time frame: 10 years
Local, regional and distant relapse rate
Time frame: 10 years
Disease free survival
Time frame: 10 years
Overall survival
Time frame: 10 years
Tumor infiltrating lymphocytes
Time frame: up to 12 months
Circulating tumor DNA
Time frame: up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Desiree van den Bongard, MD PhD principal investigator
UMC Utrecht
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 MR-guided single dose preoperative PBI in people with Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 12 inclusion and 11 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: withdrawn, as of the sponsor's last update on 26 Feb 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 Netherlands. 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 withdrawn before enrolling participants, so there are no results.
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?
Pathologic complete response (pCR) (time frame: up to 12 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 26 Feb 2021.