Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUNICANCER
About this trial
The advent of CDK4/6 inhibitors (drugs designed to block the action of CDK4/6 proteins, which play a key role in cell proliferation) has improved treatment prospects for patients with metastatic breast cancer whose tumour cells express hormone receptors but not the HER2 protein (HR+/HER2-). The NATALEE study showed that the addition of ribociclib for three years to conventional adjuvant hormone therapy (i.e. after surgery) prolonged survival free of invasive disease (i.e. extending to surrounding tissues) in patients with early HR breast cancer+ /HER2-. Unlike other studies, NATALEE included a group of patients at intermediate risk of recurrence, usually treated with adjuvant chemotherapy before receiving hormone therapy. However, the benefit of adjuvant chemotherapy in these patients is uncertain. The hypothesis of the NoLEEta study is that by using the CDK 4/6 inhibitor, patients could avoid adjuvant chemotherapy and therefore be spared the side-effects associated with this chemotherapy, without reducing the efficacy of the treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must have signed a written informed consent prior to any trial-specific screening procedure.
Patient is ≥ 18 years old.
Patient is female with known menopausal status at the time of randomization.
Patient underwent bilateral oophorectomy, or
Disqualifiers
Patient has received any neoadjuvant chemotherapy since her breast cancer diagnosis or has received any prior CDK4/6 inhibitor.
Breast cancer diagnosed while patient was receiving tamoxifen, raloxifene or aromatase inhibitors (AIs) for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization.
Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy or peanut allergy).
Patient with evidence or history of distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition), inflammatory breast cancer, breast cancer recurrence (local or distant) or a different primary breast cancer.
Trial design
Design model
Parallel
Treatments tested in this trial
Chemotherapy followed by endocrine therapy and ribociclib treatment
DrugEndocrine therapy and ribociclib treatment
De-escalation
Other interventionDe-escalation of the chemotherapy in the adjuvant setting
Treatment groups
3,902 Participants
are divided into 2 treatment groupsGroup A: Investigational arm (Arm A)Experimental treatment 1 intervention
Group B: Control arm (Arm B)Other 1 intervention
Trial outcomes
Primary outcomes
1
Invasive breast cancer-free survival (iBCFS)
iBCFS is defined as the time from the date of randomization to the date of the first event of invasive ipsilateral breast tumor recurrence, local-regional invasive recurrence, distant recurrence, death (any cause) or invasive contralateral breast cancer as assessed by investigator.
Time frame
From ramdomization to iBCFS, up to 12 years.Secondary outcomes
1
Invasive disease-free survival (iDFS)
iDFS is defined as the time from date of randomization to the date of the first iDFS event that is: i) same event as IBCFS, or ii) secondary invasive non breast cancer.
Time frame
From ramdomization to iDFS event, up to 12 years.2
Distance disease-free survival (DDFS)
DDFS is defined as the time from the date of randomization to the date of the first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
Time frame
From ramdomization to DDFS event, up to 12 years.3
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
Time frame
From ramdomization to death from any cause, up to 12 years.4
Type of iBCFS event
To evaluate the rate of the different types of iBCFS events in each treatment arm
Time frame
From ramdomization to iBCFS event, up to 12 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UNICANCER
Lead sponsor
Novartis
Collaborator
SOLTI Breast Cancer Research Group
Collaborator
GBG Forschungs GmbH
Collaborator
Latin American Cooperative Oncology Group
Collaborator
Gruppo Italiano Mammella (GIM)
Collaborator
BOOG Study Center
Collaborator
Canadian Cancer Trials Group
Collaborator
Swiss Cancer Institute
Collaborator
Menarini Silicon Biosystems, INC
Collaborator
Source ClinicalTrials.gov