Breast NeoplasmsPhase 2NEOLBCNCT03283384
Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
A Phase 2 study testing Letrozole, Chemotherapy and Ribociclib plus letrozole in people with Breast Neoplasms, run by Borstkanker Onderzoek Groep at 29 sites in Netherlands.
Trial summary
The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Letrozole, Chemotherapy and Ribociclib plus letrozole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 29 sitesNetherlands
- Study dates
- 15 Jun 2019to Aug 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women presenting with histological proven (core biopsy material) hormone receptor positive (ER≥50%, PR any), HER2 negative, stage II/ III breast cancer.
- Measurable disease (breast and/or lymph nodes)
- WHO 0-2
- Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
- Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min
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- Accessible for treatment and follow-up
- Written informed consent
- In order to be eligible to be randomized in this study, a subject must meet all of the following criteria:
- Registration in the NEOLBC trial before 2 weeks biopsy
- Use of letrozole
- Outcome central Ki67 determination in two weeks biopsy available.
Who cannot join
- Evidence of distant metastases (M1)
- Previous invasive breast cancer
- Prior chemotherapy, radiation therapy or hormonal therapy with the exception of patients who received letrozole ≤ 14 days (+ max. 4 days) prior to registration and who are still on letrozole.
- Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
- Peripheral neuropathy > grade 2, whatever the cause
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or QTcF ≥450 msec.
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- Known hypersensitivity reaction to any of the components of the treatment (peanuts, soy)
- Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
- Currently receiving any of the following substances and cannot be discontinued 7 days prior to randomisation:
- Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelo's, star-fruit, pomegranate and Seville oranges.
- That have a known risk to prolong the QT interval or induce Torsades de Pointes.
- That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- Herbal preparations/medications, dietary supplements.
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Netherlands29 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Ziekenhuisgroep Twente
Almelo
Ziekenhuis Amstelland
Amstelveen
Nederlands Kanker Instituut - Antoni van Leeuwenhoek
Amsterdam
Onze Lieve Vrouwe Gasthuis
Amsterdam
Gelre Ziekenhuizen
Apeldoorn
Amphia Ziekenhuis
Breda
Stichting Reinier Haga Groep (Reinier de Graaf Gasthuis)
Delft
Stichting Deventer Ziekenhuisgroep
Deventer
Catharina Ziekenhuis
Eindhoven
Maxima Medisch Centrum
Eindhoven
Groene Hart Ziekenhuis
Gouda
Spaarne Gasthuis
Haarlem
Ziekenhuis St. Jansdal
Harderwijk
Tergooi Ziekenhuizen
Hilversum
Westfriesgasthuis
Hoorn
Leiden University Medical Center
Leiden
Academisch Ziekenhuis Maastricht
Maastricht
Canisius-Wilhelmina Ziekenhuis
Nijmegen
Laurentius Ziekenhuis
Roermond
Bravis Ziekenhuis
Roosendaal
Antonius Ziekenhuis
Sneek
Haaglanden Medisch Centrum
The Hague
HAGA Ziekenhuis
The Hague
Ziekenhuis Rivierenland
Tiel
Elisabeth Tweesteden Ziekenhuis
Tilburg
VieCuri Medisch Centrum
Venlo
Streekziekenhuis Koningin Beatrix
Winterswijk
Isala
Zwolle
About this study
The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.
Read the detailed description
Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to continue letrozole treatment (if Ki67 <1%) or will be randomized between standard chemotherapy (AC-T) or ribociclib in combination with letrozole (if Ki67 ≥1%).
- Conditions
- Breast Neoplasms
- Being tested
- Letrozole, Chemotherapy, Ribociclib plus letrozole
- Keywords
- Breast cancer, Ribociclib, Letrozole, Chemotherapy, CDK4, CDK6, Ki67, NEOLBC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Letrozole 2.5 mg daily.
ChemotherapyDrug
Dose dense AC-T chemotherapy: consisting of 4 cycles of AC (doxorubicin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v. bolus, respectively) 2-weekly, plus G-CSF (6 mg once per cycle) 24-48 hr after chemotherapy, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m2 weekly).
Ribociclib plus letrozoleDrug
Ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Advise letrozole, treatment choice free. | Other | All patients initially start with two weeks of letrozole treatment. Patients with a Ki67 of <1% in the biopsy taken after those two weeks of treatment are advised to stay on letrozole treatment until surgery. However, treatment choice is free. Receives: Drug: Letrozole |
| Chemotherapy | Active comparator | All patients initially start with two weeks of letrozole treatment. Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)). Receives: Drug: Chemotherapy |
| Ribociclib plus letrozole | Experimental | All patients initially start with two weeks of letrozole treatment. Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)). Receives: Drug: Ribociclib plus letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) between ribociclib plus letrozole and chemotherapy in the surgical specimen.
Determine if ribociclib plus letrozole gives a ≥100% improvement in CCCA as compared to chemotherapy in the surgical specimen.
Measured: CCCA will be determined in the surgical specimen, which is around 7 months after start of initial letrozole treatment.
Secondary outcomes (8)
Correlation between Ki67 IHC scored manually, IHC scored automatically (Vectra ® 3) and Ki67 mRNA.
The correlation between the different Ki67 measurements will be determined in the primary core biopsy, two weeks biopsy and surgical specimen.
Measured: Ki67 measurements will be done in the primary core biopsy (baseline), two weeks biopsy (done after two weeks of initial letrozole treatment) and the surgical specimen (which is around 7 months after start of initial letrozole treatment).
Correlation between ER pathway activity at baseline, after two weeks letrozole and at surgery and clinical outcome.
The ER pathway activity will be determined in the primary core biopsy, two weeks biopsy and surgical specimen and then correlated with clinical outcome.
Activity will be determined using a Bayesian network model of the ER transcriptional program, which interprets the pathway target genes' mRNA levels (from Affymetrix HG-U133Plus2.0 arrays) and infers a probability that the ER pathway is active in a certain sample.
Measured: ER pathway activity will measured in the primary core biopsy (baseline), two weeks biopsy (done after two weeks of initial letrozole treatment) and the surgical specimen (which is around 7 months after start of initial letrozole treatment).
Difference in pathologic response (pCR and response according to Miller and Payne) between the randomized study arms.
The pathologic response will be determined in the surgical specimen of the patients in the randomized study arms where after the difference between the two groups can be determined.
Measured: pCR and response according to Miller and Payne will be determined in the surgical specimen, which is around 7 months after start of initial letrozole treatment.
Change in tumor biology and biomarkers (ER, PR, HER2, Rb, Ki67) at baseline, after 2 weeks letrozole and at surgery.
Tumor biology and biomarkers will be determined in the primary core biopsy, two weeks biopsy and surgical specimen, where after the change in tumor biology and biomarkers over time can be determined.
Measured: Tumor biology and biomarkers will be assessed in the primary core biopsy (baseline), two weeks biopsy (done after two weeks of initial letrozole treatment) and the surgical specimen (which is around 7 months after start of initial letrozole treatment).
Toxicity according to NCI CTCAE v4.03 all grades and grade III/IV.
Toxicities are graded according to NCI CTCAE v4.03.
Measured: Toxicity will be assessed from start treatment up to 30 days following the last dose of treatment.
Correlation of tumor measurements between standard MRI (using RECIST 1.1) and palpation (largest diameter in cm) at baseline, after AC/before T or 8 weeks of definitive neoadjuvant therapy and pre-surgery.
The correlation of tumor measurements between MRI and palpation will be determined at three different time points.
Measured: Tumor measurements (MRI and palpation) will be performed at baseline, after AC/before T or 8 weeks of definitive neoadjuvant therapy and pre-surgery (which is around 7 months after start of initial letrozole treatment).
Descriptive analysis of event free survival (EFS) at 3 and 5 years.
EFS is defined as the time from randomization to the first date of local, regional, or distant relapse, second primary invasive breast cancer including contralateral breast cancer, progression according to RECIST 1.1 or death due to any cause which ever occurred first.
Measured: EFS will be determined after 3 and 5 years.
Descriptive analysis of overall survival (OS) at 3 and 5 years.
OS is defined as the time from randomization to date of death.
Measured: Time Frame: OS will be determined after 3 and 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start15 Jun 2019
- Primary completion6 Dec 2022
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Borstkanker Onderzoek Groep
- Sponsor type
- Research network
- Collaborators
- Novartis, Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Judith R Kroep, MD PhD, Principal investigator, Leiden University Medical CenterSabine C Linn, Prof. MD, Principal investigator, The Netherlands Cancer InstituteGerrit-Jan Liefers, MD PhD, Principal investigator, Leiden University Medical CenterA. E van Leeuwen-Stok, PhD, Study director, BOOG Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283384
- Sponsor's protocol ID
- BOOG-2017-01
- Other IDs
- 2017-000676-29, 2017
- Acronym
- NEOLBC
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2017
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
- ClinicalTrials.gov ID
- NCT03283384
- Acronym / sponsor ID
- NEOLBC / BOOG-2017-01
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, Ribociclib, Letrozole, Chemotherapy, CDK4, CDK6, Ki67, NEOLBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Borstkanker Onderzoek GroepResearch network
- Collaborators
- Novartis, Philips Healthcare
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Sep 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.
The aim of this prospective, randomized, multicenter, open-label, phase II study is to test if chemotherapy can be replaced by the combination of ribociclib plus letrozole as a neo-adjuvant therapy for patients with non-metastatic primary luminal breast cancer.
Detailed description
Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to continue letrozole treatment (if Ki67 <1%) or will be randomized between standard chemotherapy (AC-T) or ribociclib in combination with letrozole (if Ki67 ≥1%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Advise letrozole, treatment choice free. | Other | Drug: LetrozoleAll patients initially start with two weeks of letrozole treatment. Patients with a Ki67 of <1% in the biopsy taken after those two weeks of treatment are advised to stay on letrozole treatment until surgery. However, treatment choice is free. |
| Chemotherapy | Active comparator | Drug: ChemotherapyAll patients initially start with two weeks of letrozole treatment. Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)). |
| Ribociclib plus letrozole | Experimental | Drug: Ribociclib plus letrozoleAll patients initially start with two weeks of letrozole treatment. Patients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Postmenopausal women presenting with histological proven (core biopsy material) hormone receptor positive (ER≥50%, PR any), HER2 negative, stage II/ III breast cancer.
- Measurable disease (breast and/or lymph nodes)
- WHO 0-2
- Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
Key exclusion criteria (14 listed)
- Evidence of distant metastases (M1)
- Previous invasive breast cancer
- Prior chemotherapy, radiation therapy or hormonal therapy with the exception of patients who received letrozole ≤ 14 days (+ max. 4 days) prior to registration and who are still on letrozole.
- Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
- Peripheral neuropathy > grade 2, whatever the cause
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 |
|---|---|---|
| LetrozoleLetrozole 2.5 mg daily. | Drug | Advise letrozole, treatment choice free. |
| ChemotherapyDose dense AC-T chemotherapy: consisting of 4 cycles of AC (doxorubicin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v. bolus, respectively) 2-weekly, plus G-CSF (6 mg once per cycle) 24-48 hr after chemotherapy, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m2 weekly). | Drug | Chemotherapy |
| Ribociclib plus letrozoleRibociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks). | Drug | Ribociclib plus letrozole |
Primary outcome
Difference in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) between ribociclib plus letrozole and chemotherapy in the surgical specimen.
Time frame: CCCA will be determined in the surgical specimen, which is around 7 months after start of initial letrozole treatment.
Determine if ribociclib plus letrozole gives a ≥100% improvement in CCCA as compared to chemotherapy in the surgical specimen.
8 secondary outcomes
Correlation between Ki67 IHC scored manually, IHC scored automatically (Vectra ® 3) and Ki67 mRNA.
Time frame: Ki67 measurements will be done in the primary core biopsy (baseline), two weeks biopsy (done after two weeks of initial letrozole treatment) and the surgical specimen (which is around 7 months after start of initial letrozole treatment).
Correlation between ER pathway activity at baseline, after two weeks letrozole and at surgery and clinical outcome.
Time frame: ER pathway activity will measured in the primary core biopsy (baseline), two weeks biopsy (done after two weeks of initial letrozole treatment) and the surgical specimen (which is around 7 months after start of initial letrozole treatment).
Difference in pathologic response (pCR and response according to Miller and Payne) between the randomized study arms.
Time frame: pCR and response according to Miller and Payne will be determined in the surgical specimen, which is around 7 months after start of initial letrozole treatment.
Change in tumor biology and biomarkers (ER, PR, HER2, Rb, Ki67) at baseline, after 2 weeks letrozole and at surgery.
Time frame: Tumor biology and biomarkers will be assessed in the primary core biopsy (baseline), two weeks biopsy (done after two weeks of initial letrozole treatment) and the surgical specimen (which is around 7 months after start of initial letrozole treatment).
Toxicity according to NCI CTCAE v4.03 all grades and grade III/IV.
Time frame: Toxicity will be assessed from start treatment up to 30 days following the last dose of treatment.
Correlation of tumor measurements between standard MRI (using RECIST 1.1) and palpation (largest diameter in cm) at baseline, after AC/before T or 8 weeks of definitive neoadjuvant therapy and pre-surgery.
Time frame: Tumor measurements (MRI and palpation) will be performed at baseline, after AC/before T or 8 weeks of definitive neoadjuvant therapy and pre-surgery (which is around 7 months after start of initial letrozole treatment).
Descriptive analysis of event free survival (EFS) at 3 and 5 years.
Time frame: EFS will be determined after 3 and 5 years.
Descriptive analysis of overall survival (OS) at 3 and 5 years.
Time frame: Time Frame: OS will be determined after 3 and 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Information NEOLBC study on BOOG website (sponsor).Link provided by the sponsor.
- 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.
Judith R Kroep, MD PhD principal investigator
Leiden University Medical Center
Sabine C Linn, Prof. MD principal investigator
The Netherlands Cancer Institute
Gerrit-Jan Liefers, MD PhD principal investigator
Leiden University Medical Center
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole, Chemotherapy and Ribociclib plus letrozole in people with Breast Neoplasms, run by Borstkanker Onderzoek Groep at 29 sites 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 14 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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?
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?
Difference in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) between ribociclib plus letrozole and chemotherapy in the surgical specimen. (time frame: CCCA will be determined in the surgical specimen, which is around 7 months after start of initial letrozole treatment.). 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 1 Oct 2026.