C50 Cancer de mama
Conditions
Interventions
Camizestrant (150 mg, once daily) with or without LHRH agonist(s). - Continue the standard ET of investigator’s choice (aromatase inhibitors [AI
exemestane, letrozole, anastrozole] with or without luteinising hormone-releasing hormone [LHRH] agonist[s] or tamoxifen, standard dose per investigator, once daily)
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women and men; =18 years at the time of screening (or per national guidelines) • Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol. • Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy • Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET • Prior adjuvant therapy with abemaciclib for 2 years is allowed • Eastern Cooperative Oncology Group (ECOG) performance status of = 1 • Adequate organ and marrow function
Exclusion criteria
Exclusion criteria: • Inoperable locally advanced or metastatic breast cancer • Pathological complete response following treatment with neoadjuvant therapy • History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation • Any evidence of severe or uncontrolled systemic diseases which, in the investigator’s opinion precludes participation in the study or compliance • Known LVEF 470 ms at screening • Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions • Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors (eg, denosumab) • Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant • Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding • Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, , known hypersensitivity or intolerance to LHRH agonists, that would preclude the patient from receiving any LHRH agonist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| STEEP 2.0 criteria (Tolaney et al 2021) NAME OF THE RESULT: Invasive Breast cancer free-survival (IBCFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: time from randomisation until date of first occurrence of: • Invasive ipsilateral breast tumour recurrence (invasive IBTR) • Locoregional invasive breast cancer recurrence • Distant recurrence • Contralateral invasive breast cancer • Death attributable to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration) NAME OF THE RESULT: PK (pharmacokinetic(s)) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Before treatment;STEEP 2.0 criteria (Tolaney et al 2021) NAME OF THE RESULT: Invasive Breast cancer free-survival (IBCFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: time from randomisation until date of first occurrence of: • Invasive ipsilateral breast tumour recurrence (invasive IBTR) • Locoregional invasive breast cancer recurrence • Distant recurrence • Contralateral invasive breast cancer • Death attributable to any cause.;STEEP 2.0 criteria (Tolaney et al 2021) NAME OF THE RESULT: invasive disease-free survival (IDFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: time from randomisation until date of first occurrence of one of the following events: • Invasive IBTR • Locoregional invasive breast cancer recurrence • Distant recurrence • Contralateral invasive breast cancer • Second primary non-breast invasive cancer • Death attributable to any cause.;STEEP 2.0 criteria (Tolaney et al 2021) NAME OF THE RESULT: distant relapse-free survival (DRFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.;STEEP 2.0 criteria (Tolaney et al 2021) NAME OF THE RESULT: overall survival (OS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: time from randomisation until death from any cause.;TEAEs (treatment-emergent adverse event), Clinical laboratory tests, vital signs, and physical examinations NAME OF THE RESULT: Security PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIM | — |
Countries
Peru
Contacts
Public ContactFlor de Liz Jacome
LABCORP PERU SERVICES S.A.
Outcome results
None listed