Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer. MedDRA version: 23.0 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 23.0 Level: LLT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 23.
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants who received adjuvant chemotherapy or no chemotherapy must have the following: – No pathological involved nodes (pN0) and primary tumor larger than 1 cm, and must fulfill at least one of the features: Grade 3 or Ki67=20% or Oncotype DX =26 (if available) or High-Risk MammaPrint (if available) or – Pathological node-positive disease (microscopic and/or macroscopic tumor involvement, =pN1) and will be stratified in medium or high risk based on additional biological criteria: Grade, Ki67, Oncotype DX or MammaPrint -Participants who received neoadjuvant chemotherapy must have residual disease in lymph nodes (=ypN1) after neoadjuvant chemotherapy. - Participants with any pT primary tumor and pN2 or any pT primary tumor and pN3 or pT4 primary tumor and any pN. - Participants who have documented ER+ (positive) tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as = 1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines or European Society of Medical Oncology (ESMO) guidelines or any national guidelines with criteria conforming to ASCO/CAP or ESMO guidelines. - Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (ALND and/or SLNB). - Participants who received adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: - Participants who have been diagnosed with Stage IV breast cancer - Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC. - Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or are currently enrolled in any other type of medical research that is scientifically or medically incompatible with this study - Participants receiving or planning to receive a CDK4/6i as (neo)adjuvant therapy. Short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed. - Participants who have active cardiac disease or history of cardiac dysfunction - Participants who have a history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of giredestrant over the control treatment ;Secondary Objective: • To evaluate the efficacy of giredestrant compared with Endocrine Therapy of Physician’s Choice (TPC) • To evaluate the safety of giredestrant compared with TPC • To characterize giredestrant pharmacokinetics (PK) • To evaluate health status utility scores of participants treated with giredestrant compared with TPC ;Primary end point(s): 1. Invasive disease-free survival (IDFS), defined as the time from randomization to first occurrence of one of the following IDFS events; ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, and death from any cause;Timepoint(s) of evaluation of this end point: 1. Up to approximately 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival, defined as the time from randomization to death from any cause 2. IDFS (per STEEP), including second primary non-breast cancer, defined in the same way as the primary IDFS, but including second primary non-breast invasive cancer as an event (with the exception of non-melanoma skin cancers and in situ carcinomas of any site) 3. Disease-free survival (DFS), defined as the time from randomization to first occurrence of an IDFS (per STEEP) event, including second primary non-breast cancer event or contralateral or ipsilateral DCIS 4. Distant recurrence-free interval (DRFI), defined as the time from randomization to first occurrence of a DRFI event 5. Locoregional recurrence-free interval (LRRFI), defined as the time from randomization to first occurrence of an LRRFI event 6. Mean and mean change from baseline in physical functioning, role functioning, and global health status/ quality of life (QoL) at relevant timepoints as assessed through use of the European Organisation for the Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30) respective scale scores 7. Incidence and severity of adverse events, with severity determined according to NCI CTCAE 5.0 8. Change from baseline in targeted vital signs and clinical laboratory test results 9. Plasma concentrations of giredestrant at specified timepoints 10. Change from baseline in EuroQol 5-Dimension Questionnaire, 5-level version (EQ 5D-5L) index-based and visual analogue scale scores at relevant timepoint ;Timepoint(s) of evaluation of this end point: 1-10. Up to approximately 10 years | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Czech Republic, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Latvia, Malaysia, Mexico, Netherlands, North Macedonia, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Kingdom, United States, Viet Nam
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed