Radiation Therapy, Breast Cancer, Sequential Partial Breast IrradiationPhase 1/2Néo-APBI-01NCT02806258
Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone
A Phase 1/2 study testing Accelerated partial breast irradiation and Chemotherapy in people with Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation and Intermediate and High-risk Luminal and Triple Negative Breast Cancer, run by University Hospital, Grenoble at 6 sites in France.
Trial summary
In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation, Intermediate and High-risk Luminal and Triple Negative Breast Cancer
- What is being tested?
- Accelerated partial breast irradiation and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 6 sitesFrance
- Study dates
- 26 Apr 2016to 16 May 2025
- Phase
- Phase 1/2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Histologically confirmed invasive carcinoma of the breast
- Patient who desires breast conservation
- Tumor stage T1N1, T2-3 N0-1
- Operable BC for which an indication for CT is determined, including T1N1 and high risk T2-3 N0-1 tumors.
- Lobular and/or ductal invasive carcinoma
Show all 13Show fewer
- Confirmation by imaging (standard +/- MRI) of unicentric and unilateral disease
- Luminal B (defined by hormone receptor positive and grade II-III (if available from core biopsy) and Ki67 ≥ 15% or by genomic analysis) and TNG subtypes
- HER2 negative
- No distant metastases
- No contraindication for PST with anthracycline and/or taxane based regimens
- Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator with the aid of written information.
Who cannot join
- Patients considered too frail for CT whatever their age.
- Breast cancer clinical grade T4 and /or with major nodal involvement N2 (clinically, US, MRI or PET-CT).
- Lumpectomy is considered to be possible with an anticipated favourable cosmetic outcome considering the tumor size/breast size
- Multicentricity that would not allow BCS as confirmed by breast imaging
- Uni or bilateral inflammatory (T4d) BC
- Metastatic disease
Show all 16Show fewer
- Other histology types: ciribriform or tubular or mucinous or epideroid carcinomas
- Her2 positive
- No signed consent to participate in the study
- Previous malignancy (except non melanoma skin cancer, thyroid carcinoma, non-invasive cancers outside the breast and patients with previous cancer in remission since more > 5 years)
- Patients with psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule
- Patients unwilling or unable to comply with the protocol (especially necessity to undergo breast surgery despite clinical complete response)
- Patients who have received any other investigational drugs within 30 days prior to the screening visit
- Pregnancy
- Active connective tissue disease involving the skin
- Patients with other concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study .
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHI Créteil
Créteil
CHU de Grenoble
Grenoble, 38043
AP-HP Henri mondor
Paris
CHU Avicenne
Paris
H. Hartmann Institute of Radiotherapy and Radiosurgery
Paris
Tenon hospital
Paris
About this study
Official title: Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone, for Triple Negative Locally Advanced Breast Cancers and Luminal B Proliferating, Inaccessible to a Conservative Surgery the Outset
In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI
Read the detailed description
Phase I:
The total APBI dose is set to level I at 20 Gy (in 10 fractions over 5 days; n=5) and then level II at 24 Gy (in 12 fractions over 6 days) delivered to the tumor using two fractions/day of 2 Gy spaced by at least 6 hours. The biological effective dose (BED) is 32 Gy and 47 Gy for alpha/beta of 10 and 3.5, respectively. As compared to the standard fractionation of 2 Gy/fraction the BED is 26.8 Gy and 30 Gy for the 2 values of alpha/beta.
In case of the impossibility to deliver two fractions/day, patients should be treated using a single fraction of 3.125 Gy/day up to 8 fractions (total dose of 25 Gy). The BED is 32.8 Gy and 47.3 Gy for alpha/beta of 10 and 3.5, respectively. As compared to the standard fractionation of 2 Gy/fraction the BED is 27.3 Gy and 30.1 Gy for the 2 values of alpha/beta.
In both schemes, 95% of the prescribed dose should be delivered in at least 90% of the PTV.
All patients who undergo BCS after the end of PST-APBI will receive postoperative WBI (+/- nodal areas) delivering a total dose of 45-50 Gy using standard fractionation (1.8 or 2 Gy) or hypofractionated schedules using > 15 fractions in 3 weeks. Technique and boost delivery will be left at the investigator's discretion and local policy. Patients who had TM should also receive PMRT if indicated delivering 45-50.4 Gy using standard fractionation (1.8 or 2 Gy). If the patient did not complete a full course of PST prior to surgery, CT will be given prior to or immediately following postoperative RT depending on the institutional protocol. Other post-operative treatments will be at the investigator's discretion. Adjuvant hormonal treatment will be administered to HR+ patients.
Phase II:
This is a phase II randomized study designed for patients with newly diagnosed intermediate and high risk non-metastatic BC who are candidates for a minimum of six cycles of PST using anthracycline and/or taxane based regimens, who desire BCS but are not eligible due to tumor/breast ratio. All patients will have a clip in the tumor bed before or after the first 1-2 cycles of PST.
Eligible patients who have consented to participate in the study will be randomized to treatment Arm A or B:
Arm A: 6-8 cycles of PST using anthracycline and/or taxane based regimens, according to their physician's preference and center policy.
Arm B: The patients will receive 3D conformal or other modality (eg IMRT, VMAT) APBI during their PST sequence. APBI will be planned sequentially between the PST cycles, 2 weeks after the 3rd/6 or the 4th/8 cycle of PST.
For the purpose of quality of the target volume definition, it is mandatory to make a planning CT-scan in treatment position before the initiation of chemotherapy. MRI or US fusion with CT scan images can increase target volume definition and should be used if necessary. For all patients, treatment planning should be made on a planning CT-scan shortly preceding the initiation of radiation therapy to take possible tumor shrinkage and breast shape changes into account.
The CTV is defined as GTV + 1cm. The margin to the PTV depends on the measurements of the center and thereby the positioning and verification techniques. If this is not known, PTV should be defined as CTV + 1 cm around. The PTV should be used for beam shaping while for dose evaluation and calculation a PTVeval will be defined as PTV excluding the skin + 5 mm and the thoracic wall (ribs and intercostal muscles). IMRT should not be used in the protocol. The PTVeval should not exceed 40% of the total breast volume.
Study Arms:
All patients must undergo surgery even in cases of clinical complete response. Surgery will be scheduled 4 to 6 weeks from the last day of PST.
Modified radical mastectomy is indicated in case of limited clinical response, or progressive disease, or if tumor size/breast size does not permit BCS. The decision should be based on US or MRI confirmation of the response. Post TM radiation therapy should be applied according to the center's guidelines. High risk patients should receive nodal radiotherapy policy.
All patients who undergo BCS after the end of PST-APBI, will receive postoperative RT. This will consist of WBI (+/- nodal areas) to a total dose of 45-50 Gy using standard fractionation (1.8 or 2 Gy) or hypofractionated schedules using > 15 fractions in 3 weeks. Technique and boost delivery will be left at the investigator's discretion and local policy. Patients who had TM should also receive PMRT, 45-50.4 Gy using standard fractionation (1.8 or 2 Gy). If the patient did not complete a full course of PST prior to surgery, CT will be given prior to or immediately following postoperative RT depending on the institutional protocol. Other post-operative treatments will be at the investigator's discretion. Adjuvant hormonal treatment will be administered to HR+ patients.
Standard protocol:
The patients randomized to the standard treatment arm will receive a minimum of 6-8 cycles of PST using an anthracycline and/or taxane based regimen. Surgery will consist of BCS or TM according to clinical response and tumor/breast volume ratio obtained after PST. After surgery, the patients will receive standard RT to the whole breast (45-50.4 Gy in 25-28 fractions) or equivalent using hypofractionated schedule > 15 fractions in 3 weeks. RT technique and the addition of boost are left to the investigator decision according to institutional protocol. Adjuvant ET will be administered to HR+ patients after the end of radiotherapy during at least 5 years.
Auxiliary translational study Tumor core biopsies for translational studies and genetic analysis will be obtained at baseline and from the resected tumor at surgery following PST +/- APBI.
This study will focus on the prediction of pCR using cell metabolism, hypoxia and angiogenesis markers (Scottish Group). Another objective is to correlate these markers with the metabolic imaging for pCR prediction (Oscar Lambret Center, France).
- Conditions
- Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation, Intermediate and High-risk Luminal and Triple Negative Breast Cancer
- Being tested
- Accelerated partial breast irradiation, Chemotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated partial breast irradiationRadiation
To date, there is no report on external beam APBI associated with CT in the neoadjuvant setting.In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI.
ChemotherapyDrug
minimum of six cycles of PST using anthracycline and/or taxane based regimens
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | 6-8 cycles of Primary systemic therapy using anthracycline and/or taxane based regimens, according to their physician's preference and center policy Receives: Drug: Chemotherapy |
| Arm B | Experimental | The patients will receive 3D conformal or other modality (eg IMRT, VMAT) APBI during their PST sequence. APBI will be planned sequentially between the Primary systemic therapy cycles, 2 weeks after the 3rd/6 or the 4th/8 cycle of PST. Receives: Radiation: Accelerated partial breast irradiation; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR rates
Pathological complete response (pCR), defined by the absence of invasive residual primary tumor in the breast and lymph node.The primary objective of this study is to compare pCR rates after Primary Systemic Therapy (PST) plus APBI versus PST alone in patients with luminal and TNG BC prior to BC surgery.
Measured: At the end of chemotherapy: up to 21 weeks
Secondary outcomes (3)
PCR 2
Breast and axilla pathological complete response rate (pCR2)
Measured: At the end of chemotherapy: up to 21 weeks
Breast conservation rate
Breast conservation rate
Measured: Intraoperative
Acute and late toxicities
Acute and late toxicities (CTCAE v 4.0)
Measured: At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start26 Apr 2016
- Primary completion16 May 2024
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation Therapy, Breast Cancer, Sequential Partial Breast IrradiationStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Gabelle Flandin, Dr, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806258
- Sponsor's protocol ID
- 38RC14.454
- Acronym
- Néo-APBI-01
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2016
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
To NH, Gabelle-Flandin I, Luong TMH, Loganadane G, Ouidir N, Boukhobza C, Grellier N, Verry C, Thiolat A, Cohen JL, Radosevic-Robin N, Belkacemi Y. Pathologic Response to Neoadjuvant Sequential Chemoradiation Therapy in Locally Advanced Breast Cancer: Preliminary, Translational Results from the French Neo-APBI-01 Trial. Cancers (Basel). 2023 Mar 29;15(7):2030. doi: 10.3390/cancers15072030.
PubMed 37046691
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone, for Triple Negative Locally Advanced Breast Cancers and Luminal B Proliferating, Inaccessible to a Conservative Surgery the Outset
- ClinicalTrials.gov ID
- NCT02806258
- Acronym / sponsor ID
- Néo-APBI-01 / 38RC14.454
- Conditions
- Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation, Intermediate and High-risk Luminal and Triple Negative Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 20 Jun 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.
In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI
Detailed description
Phase I:
The total APBI dose is set to level I at 20 Gy (in 10 fractions over 5 days; n=5) and then level II at 24 Gy (in 12 fractions over 6 days) delivered to the tumor using two fractions/day of 2 Gy spaced by at least 6 hours. The biological effective dose (BED) is 32 Gy and 47 Gy for alpha/beta of 10 and 3.5, respectively. As compared to the standard fractionation of 2 Gy/fraction the BED is 26.8 Gy and 30 Gy for the 2 values of alpha/beta.
In case of the impossibility to deliver two fractions/day, patients should be treated using a single fraction of 3.125 Gy/day up to 8 fractions (total dose of 25 Gy). The BED is 32.8 Gy and 47.3 Gy for alpha/beta of 10 and 3.5, respectively. As compared to the standard fractionation of 2 Gy/fraction the BED is 27.3 Gy and 30.1 Gy for the 2 values of alpha/beta.
In both schemes, 95% of the prescribed dose should be delivered in at least 90% of the PTV.
All patients who undergo BCS after the end of PST-APBI will receive postoperative WBI (+/- nodal areas) delivering a total dose of 45-50 Gy using standard fractionation (1.8 or 2 Gy) or hypofractionated schedules using > 15 fractions in 3 weeks. Technique and boost delivery will be left at the investigator's discretion and local policy. Patients who had TM should also receive PMRT if indicated delivering 45-50.4 Gy using standard fractionation (1.8 or 2 Gy). If the patient did not complete a full course of PST prior to surgery, CT will be given prior to or immediately following postoperative RT depending on the institutional protocol. Other post-operative treatments will be at the investigator's discretion. Adjuvant hormonal treatment will be administered to HR+ patients.
Phase II:
This is a phase II randomized study designed for patients with newly diagnosed intermediate and high risk non-metastatic BC who are candidates for a minimum of six cycles of PST using anthracycline and/or taxane based regimens, who desire BCS but are not eligible due to tumor/breast ratio. All patients will have a clip in the tumor bed before or after the first 1-2 cycles of PST.
Eligible patients who have consented to participate in the study will be randomized to treatment Arm A or B:
Arm A: 6-8 cycles of PST using anthracycline and/or taxane based regimens, according to their physician's preference and center policy.
Arm B: The patients will receive 3D conformal or other modality (eg IMRT, VMAT) APBI during their PST sequence. APBI will be planned sequentially between the PST cycles, 2 weeks after the 3rd/6 or the 4th/8 cycle of PST.
For the purpose of quality of the target volume definition, it is mandatory to make a planning CT-scan in treatment position before the initiation of chemotherapy. MRI or US fusion with CT scan images can increase target volume definition and should be used if necessary. For all patients, treatment planning should be made on a planning CT-scan shortly preceding the initiation of radiation therapy to take possible tumor shrinkage and breast shape changes into account.
The CTV is defined as GTV + 1cm. The margin to the PTV depends on the measurements of the center and thereby the positioning and verification techniques. If this is not known, PTV should be defined as CTV + 1 cm around. The PTV should be used for beam shaping while for dose evaluation and calculation a PTVeval will be defined as PTV excluding the skin + 5 mm and the thoracic wall (ribs and intercostal muscles). IMRT should not be used in the protocol. The PTVeval should not exceed 40% of the total breast volume.
Study Arms:
All patients must undergo surgery even in cases of clinical complete response. Surgery will be scheduled 4 to 6 weeks from the last day of PST.
Modified radical mastectomy is indicated in case of limited clinical response, or progressive disease, or if tumor size/breast size does not permit BCS. The decision should be based on US or MRI confirmation of the response. Post TM radiation therapy should be applied according to the center's guidelines. High risk patients should receive nodal radiotherapy policy.
All patients who undergo BCS after the end of PST-APBI, will receive postoperative RT. This will consist of WBI (+/- nodal areas) to a total dose of 45-50 Gy using standard fractionation (1.8 or 2 Gy) or hypofractionated schedules using > 15 fractions in 3 weeks. Technique and boost delivery will be left at the investigator's discretion and local policy. Patients who had TM should also receive PMRT, 45-50.4 Gy using standard fractionation (1.8 or 2 Gy). If the patient did not complete a full course of PST prior to surgery, CT will be given prior to or immediately following postoperative RT depending on the institutional protocol. Other post-operative treatments will be at the investigator's discretion. Adjuvant hormonal treatment will be administered to HR+ patients.
Standard protocol:
The patients randomized to the standard treatment arm will receive a minimum of 6-8 cycles of PST using an anthracycline and/or taxane based regimen. Surgery will consist of BCS or TM according to clinical response and tumor/breast volume ratio obtained after PST. After surgery, the patients will receive standard RT to the whole breast (45-50.4 Gy in 25-28 fractions) or equivalent using hypofractionated schedule > 15 fractions in 3 weeks. RT technique and the addition of boost are left to the investigator decision according to institutional protocol. Adjuvant ET will be administered to HR+ patients after the end of radiotherapy during at least 5 years.
Auxiliary translational study Tumor core biopsies for translational studies and genetic analysis will be obtained at baseline and from the resected tumor at surgery following PST +/- APBI.
This study will focus on the prediction of pCR using cell metabolism, hypoxia and angiogenesis markers (Scottish Group). Another objective is to correlate these markers with the metabolic imaging for pCR prediction (Oscar Lambret Center, France).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Chemotherapy6-8 cycles of Primary systemic therapy using anthracycline and/or taxane based regimens, according to their physician's preference and center policy |
| Arm B | Experimental | Radiation: Accelerated partial breast irradiation, Drug: ChemotherapyThe patients will receive 3D conformal or other modality (eg IMRT, VMAT) APBI during their PST sequence. APBI will be planned sequentially between the Primary systemic therapy cycles, 2 weeks after the 3rd/6 or the 4th/8 cycle of PST. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients ≥ 18 years of age
- Histologically confirmed invasive carcinoma of the breast
- Patient who desires breast conservation
- Tumor stage T1N1, T2-3 N0-1
- Operable BC for which an indication for CT is determined, including T1N1 and high risk T2-3 N0-1 tumors.
Key exclusion criteria (16 listed)
- Patients considered too frail for CT whatever their age.
- Breast cancer clinical grade T4 and /or with major nodal involvement N2 (clinically, US, MRI or PET-CT).
- Lumpectomy is considered to be possible with an anticipated favourable cosmetic outcome considering the tumor size/breast size
- Multicentricity that would not allow BCS as confirmed by breast imaging
- Uni or bilateral inflammatory (T4d) BC
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 |
|---|---|---|
| Accelerated partial breast irradiationTo date, there is no report on external beam APBI associated with CT in the neoadjuvant setting.In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI. | Radiation | Arm B |
| Chemotherapyminimum of six cycles of PST using anthracycline and/or taxane based regimens | Drug | Arm A, Arm B |
Primary outcome
PCR rates
Time frame: At the end of chemotherapy: up to 21 weeks
Pathological complete response (pCR), defined by the absence of invasive residual primary tumor in the breast and lymph node.The primary objective of this study is to compare pCR rates after Primary Systemic Therapy (PST) plus APBI versus PST alone in patients with luminal and TNG BC prior to BC surgery.
3 secondary outcomes
PCR 2
Time frame: At the end of chemotherapy: up to 21 weeks
Breast conservation rate
Time frame: Intraoperative
Acute and late toxicities
Time frame: At the end of chemotherapy and after surgery and after radiotherapy: up to 30 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 37046691To NH, Gabelle-Flandin I, Luong TMH, Loganadane G, Ouidir N, Boukhobza C, Grellier N, Verry C, Thiolat A, Cohen JL, Radosevic-Robin N, Belkacemi Y. Pathologic Response to Neoadjuvant Sequential Chemoradiation Therapy in Locally Advanced Breast Cancer: Preliminary, Translational Results from the French Neo-APBI-01 Trial. Cancers (Basel). 2023 Mar 29;15(7):2030. doi: 10.3390/cancers15072030.
- Individual participant dataSharing planned: Yes
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.
Isabelle Gabelle Flandin, Dr principal investigator
CHU Grenoble Alpes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Accelerated partial breast irradiation and Chemotherapy in people with Radiation Therapy, Breast Cancer, Sequential Partial Breast Irradiation and Intermediate and High-risk Luminal and Triple Negative Breast Cancer, run by University Hospital, Grenoble at 6 sites in France.
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 13 inclusion and 16 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 Dec 2025. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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. 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?
PCR rates (time frame: At the end of chemotherapy: up to 21 weeks). 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 NCT02806258, which also lists 1 linked publication.
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 Dec 2025.