Breast CancerALIENORNCT03357120
Circulating Tumor DNA After Neoadjuvant Chemotherapy
A study testing Follow-up after neoadjuvant chemotherapy in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
Trial summary
Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Follow-up after neoadjuvant chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2017to 16 Apr 2025
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years (no age limit).
- Women or men.
- Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):
- Locally advanced tumor known to be inoperable from the start:
- cT4a, b, c, d whatever the cN
- or cN2 or cN3 whatever the cT.
Show all 17Show fewer
- Operable tumors:
- cT2cN1 or cT3cN0 or cT3N1,
- or cT2cN0 for which ganglionic invasion has been proven by cytology or histology.
- Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0).
- Unilateral or bilateral breast cancer. Multifocality is accepted.
- Patients who received 6 to 8 cycles of neoadjuvant chemotherapy.
- Preoperative radiation therapy allowed.
- Breast surgery performed and pathology report of a non-complete histological response (i.e. all the different results of ypT0 /is ypN0).
- Signed informed consent.
- Patients affiliated to a French social security scheme in accordance with Article 1121-11 of the French Code of Public Health.
- Possible inclusion in another interventional research (surgical, radiotherapy or drug study).
Who cannot join
- cT2cN0 tumor without cytological or histological lymph node involvement.
- Progression during neoadjuvant chemotherapy.
- Exclusive neoadjuvant hormone therapy.
- Complete blood transfusion within 120 days prior to 1st sampling.
- History of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. However, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible.
- Patient unable to follow and comply with research procedures for geographical, social or psychological reasons.
- Patient deprived of liberty or subject to a legal protection measure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)
Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.
Read the detailed description
Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included).
Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years.
In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).
- Conditions
- Breast Cancer
- Being tested
- Follow-up after neoadjuvant chemotherapy
- Keywords
- Breast Cancer, Neoadjuvant chemotherapy, Circulating tumor DNA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up after neoadjuvant chemotherapyOther
Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated). Next Generation Sequencing (NGS) analysis will be performed on post-neoadjuvant chemotherapy residual tumor tissue samples. The mutations identified by NGS in residual tumor will be tracked in ctDNA using personalized digital PCR (dPCR) or by an NGS technique whose bioinformatics pipeline is adapted to the analysis of ctDNA.
In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).
| Study group | Role | What they receive |
|---|---|---|
| Follow-up after neoadjuvant chemotherapy | Other | Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included). Receives: Other: Follow-up after neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of the presence of ctDNA mutation(s) measured by dPCR on recurrence-free interval (RFI) at 3 years.
Measured: 3 years
Secondary outcomes (8)
Prognostic value of the presence of ctDNA mutation(s) on overall survival (OS) at 3 years.
Measured: 3 years
Prognostic value of the presence of ctDNA mutation(s) on distant-metastasis-free interval (DRFI) at 3 years.
Measured: 3 years
Prognostic value of the presence of ctDNA mutation(s) on OS at 5 years.
Measured: 5 years
Prognostic value of the presence of ctDNA mutation(s) on DRFI at 5 years.
Measured: 5 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 3 years.
Measured: 3 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFI at 3 years.
Measured: 3 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 5 years.
Measured: 5 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFIat 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start6 Oct 2017
- Primary completion10 Mar 2022
- Study completion16 Apr 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Bergonié
- Responsible party
- Sponsor
- Investigators
- Hervé BONNEFOI, MD, PhD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357120
- Sponsor's protocol ID
- IB 2017-02
- Other IDs
- ID-RCB number : 2017-A00939-44
- Acronym
- ALIENOR
- Status last verified
- Sep 2026
- First submitted
- 9 Nov 2017
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Tumoral DNA Mutations (Sequential Assessment) Following Neoadjuvant Chemotherapy for Breast Cancer: Clinical Validity (ALIENOR Study)
- ClinicalTrials.gov ID
- NCT03357120
- Acronym / sponsor ID
- ALIENOR / IB 2017-02
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Neoadjuvant chemotherapy, Circulating tumor DNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Fondation Bergonié
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 29 Nov 2017 (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.
Trial assessing the prognostic value of ctDNA mutations from samples taken sequentially in patients with invasive breast cancer initially treated with neoadjuvant chemotherapy and whose tumor is not in complete histological response.
Detailed description
Patients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included).
Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years.
In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up after neoadjuvant chemotherapy | Other | Other: Follow-up after neoadjuvant chemotherapyPatients with an invasive breast cancer on neoadjuvant chemotherapy (with the exception of cT2cN0 tumors) are preselected before the surgical procedure. They are definitely included during the post-surgery visit following the analysis of the surgical specimen (only patients whose tumor did not achieve a complete pathological response are included). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years (no age limit).
- Women or men.
- Invasive breast cancer proven histologically at diagnosis (before neoadjuvant chemotherapy):
- Lack of clinically or radiologically detectable metastases in the initial diagnosis before the neoadjuvant chemotherapy (M0).
- Unilateral or bilateral breast cancer. Multifocality is accepted.
Key exclusion criteria (7 listed)
- cT2cN0 tumor without cytological or histological lymph node involvement.
- Progression during neoadjuvant chemotherapy.
- Exclusive neoadjuvant hormone therapy.
- Complete blood transfusion within 120 days prior to 1st sampling.
- History of invasive cancer regardless of the time elapsed since the diagnosis of this cancer, including a history of contralateral invasive breast cancer. However, patients who have been treated for in situ breast cancer, basocellular skin cancer or cervical cancer treated in situ are eligible.
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 |
|---|---|---|
| Follow-up after neoadjuvant chemotherapySequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated). Next Generation Sequencing (NGS) analysis will be performed on post-neoadjuvant chemotherapy residual tumor tissue samples. The mutations identified by NGS in residual tumor will be tracked in ctDNA using personalized digital PCR (dPCR) or by an NGS technique whose bioinformatics pipeline is adapted to the analysis of ctDNA. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated). | Other | Follow-up after neoadjuvant chemotherapy |
Primary outcome
Prognostic value of the presence of ctDNA mutation(s) measured by dPCR on recurrence-free interval (RFI) at 3 years.
Time frame: 3 years
8 secondary outcomes
Prognostic value of the presence of ctDNA mutation(s) on overall survival (OS) at 3 years.
Time frame: 3 years
Prognostic value of the presence of ctDNA mutation(s) on distant-metastasis-free interval (DRFI) at 3 years.
Time frame: 3 years
Prognostic value of the presence of ctDNA mutation(s) on OS at 5 years.
Time frame: 5 years
Prognostic value of the presence of ctDNA mutation(s) on DRFI at 5 years.
Time frame: 5 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 3 years.
Time frame: 3 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFI at 3 years.
Time frame: 3 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on RFI at 5 years.
Time frame: 5 years
Prognostic value of the presence of ctDNA mutation(s) on a single sample assessment after surgery (measured by dPCR) on DRFIat 5 years.
Time frame: 5 years
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 21 Sep 2026.
- 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.
Hervé BONNEFOI, MD, PhD study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up after neoadjuvant chemotherapy in people with Breast Cancer, run by Institut Bergonié at 1 site 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 17 inclusion and 7 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 21 Sep 2026. 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 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.
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?
Prognostic value of the presence of ctDNA mutation(s) measured by dPCR on recurrence-free interval (RFI) at 3 years. (time frame: 3 years). 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 21 Sep 2026.