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Breast CancerPhase 2VIOLETNCT07428018

Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib

A Phase 2 study testing Abemaciclib in people with Breast Cancer and HER2 + Breast Cancer, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of… Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Breast Cancer, HER2 + Breast Cancer, HR Positive
What is being tested?
Abemaciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
30 Apr 2026to 30 Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • female aged 18 years or older
  • primary, histologically confirmed diagnosis of invasive breast carcinoma,
  • estrogen receptor (ER)-positive tumor, defined as ≥10% by immunohistochemistry and measured as per ASCO/CAP guidelines (Allison et al.2020). Any progesterone receptor expression is acceptable (as per local assessment)
  • documented human epidermal growth factor receptor-2 (HER2)-negative tumor as per ASCO/CAP guidelines, assessed locally,
  • stage II-IIIB as per AJCC TNM classification (8th edition). Absence of distant metastases (with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure),
  • candidate to receive neoadjuvant chemotherapy according to the indication of a multidisciplinary tumor board,
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  • not eligible to receive upfront breast conservative surgery (but considered potentially eligible to receive a BCS in case of tumor downstaging) AND/OR not candidate to sentinel lymph node dissection because of clinical node positive disease
  • Eastern Cooperative Oncology Group Performance Status 0-1,
  • The patient is able to swallow oral medications
  • normal hematologic parameters:
  • a.) absolute neutrophil count ≥ ≥1500/mm3 (1.5 × 10 9/L), b) platelets ≥ 100 × 10 9/L, c)hemoglobin ≥ 8 g/dL (≥ 80 g/L)). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion
  • normal renal function: serum creatinine concentration ≤1.5 ULN or calculated clearance ≥50 mL/min according to the Cockcroft-Gault formula,
  • normal liver function:
  • a.)serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted., b)AST and ALT ≤ 3 × ULN, c)alkaline phosphatase ≤ 2.5 × ULN,
  • women of child bearing potential must have documented negative pregnancy test within 2 weeks (preferably 7 days) prior to study entry and must agree to effective non-hormonal contraception (barrier method - condoms, diaphragm -also in conjunction with spermicidal jelly, or total abstinence) after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed during the trial,
  • willingness to undergo breast surgery after optimal neoadjuvant treatment, and to provide blood and tumor samples for the study purposes, including the submission for central assessment of Oncotype Dx test.

Who cannot join

  • presence of distant metastases (stage IV) or stage IIIC disease,
  • inflammatory or locally-advanced, inoperable breast cancer
  • previous invasive ipsilateral breast cancer at any time,
  • previous or concomitant invasive malignancy. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), if adequately treated:
  • basal or squamous cell carcinoma of the skin,
  • melanoma in situ,
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  • in situ non-breast carcinoma without invasion,
  • contra- or ipsilateral in situ breast carcinoma,
  • non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence,
  • stage I papillary thyroid cancer,
  • stage Ia carcinoma of the cervix,
  • stage Ia or b endometrioid endometrial cancer,
  • borderline or stage I ovarian cancer
  • known history of uncontrolled or symptomatic angina, uncontrolled hypertension (≥ 180/110 mmHg), uncontrolled diabetes mellitus, dyspnea at rest, chronic therapy with oxygen, a New York Heart Association (NYHA) class III or IV congestive heart failure, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • females who are pregnant or lactating (lactation has to stop before study entry)
  • the patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea),
  • The patient has had major surgery within 14 days prior to study entry.
  • The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to study entry, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.
  • The patient has active systemic bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive])
  • contraindications or known hypersensitivity to the trial medication or excipients,
  • use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

  • Istituto di Ricerche Farmacologiche Mario Negri IRCCS

    Milan, MI, 20156

Other trials in Italy

About this study

Official title: The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib

This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy

Read the detailed description

Women aged 18 years or older with histologically confirmed operable or inoperable ER-positive (>10%)/HER2-negative invasive breast carcinoma (stage II-IIIB), candidate to receive neoadjuvant chemotherapy according to the shared decision of a multidisciplinary tumor board, and who are not eligible to receive upfront breast conservative surgery AND/OR are candidate to lymph node. All eligible patients will undergo ODX RS tumor assessment in the baseline biopsy. They will receive NET plus abemaciclib or NCT for 6 months as per MDT decision, according to tumor stage, tumor histology, patient menopausal status and ODX RS results. At the end of the neoadjuvant treatment, all patients will be discussed again in a multidisciplinary tumor board and a new surgical indication will be given according to the post-treatment clinical and radiological assessment.After surgery, patients who received NET+abemaciclib may receive adjuvant chemotherapy according to the multidisciplinary tumor board indication.dissection.

Being tested
Abemaciclib
Keywords
breast, oncotype dx, abemaciclib, neoadjuvant treatment, surgical deescalation
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    neoadjuvant endocrine therapy (NET) plus abemaciclib

Study groups in NCT07428018
Study groupRoleWhat they receive
chemotherapy (NCT)No interventionNeoadjuvant chemotherapy (NCT), including sequential standard regimens with sequential anthracyclines and taxanes,
NET plus abemaciclibExperimentalneoadjuvant endocrine therapy (NET) plus abemaciclib.
Receives: Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision

    the proportion of patients with ER+/HER2- EBC who avoid (neo)adjuvant chemotherapy according to the MDT decision based on the ODX RS assessment in the tumor biopsy specimen and the availability of abemaciclib/ET option for the lower RS group

    Measured: From the date of the enrollment up to 24 months

  2. evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy

    the proportion of patients who de-escalate surgery after neoadjuvant therapy comparing the baseline surgical indication of the MDT to the effective surgery (at least one of: "from mastectomy to breast conservative surgery" OR "from lymph node dissection to sentinel node biopsy").

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
phase II, pragmatic
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07428018
Sponsor's protocol ID
VIOLET
Other IDs
2026-525457-37-00
Acronym
VIOLET
Status last verified
Mar 2026
First submitted
17 Feb 2026
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib in people with Breast Cancer and HER2 + Breast Cancer, run by Mario Negri Institute for Pharmacological Research 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 16 inclusion and 21 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: opening soon, as of the sponsor's last update on 5 Mar 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 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?

This study is still under way. Results are not available in the source record yet.

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?

determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision (time frame: From the date of the enrollment up to 24 months). 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?

On the ClinicalTrials.gov record for NCT07428018.

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 5 Mar 2026.

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