C50 Cancer de mama
Conditions
Interventions
Giredestrant 30 mg once a day - TPC (dosing acording to local prescribing information). TPC is limited to either tamoxifen or one of the specified third generation AIs: anastrozole, or letrozole or ex
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants who are capable of giving signed informed consent. - Participants (females, regardless of menopausal status, and males) who are age >= 18 years at the time of signing Informed Consent Form - Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity - Participants with bilateral synchronous invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER positivity and HER2 negativity. - Participants who have documented ER+ tumor by immunohistochemistry (IHC), as assessed locally on a primary disease specimen and defined as = 1% of tumor cells stained positive according to American Society of Clinical Oncology (ASCO) - Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines (Wolff AC et al 2018) - Participants must have undergone definitive surgery of the primary breast tumor(s). With the exception of the situations described below, the margins of the resected specimen must be histologically free of invasive tumor and /or a component of ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the participant must undergo mastectomy to be eligible. Of note, participants with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection. - Please, review the protocol for more details.
Exclusion criteria
Exclusion criteria: - Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment. - Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study - Participants receiving or planning to receive a CDK4/6i as adjuvant therapy - Participants who have active cardiac disease or history of cardiac dysfunction including any of the following: - History (within 5 years of screening) or presence of symptomatic bradycardia or resting heart rate = 50 bpm - History of angina pectoris, symptomatic pericarditis, myocardial infarction, or any cardiac arrhythmias (e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality) within 12 months prior to randomization - History of documented congestive heart failure (New York Heart Association Class II-IV) or cardiomyopathy - QT interval corrected through use of Fridericia’s formula >470 ms based on mean value of triplicate ECGs, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes - History or presence of an abnormal ECG that is clinically significant in the investigator’s opinion, including complete left bundle branch block, second- or third-degree heart block, sick sinus syndrome, or evidence of prior myocardial infarction - Participants with first-degree heart block may be considered for inclusion following consultation with a cardiologist and determination that no additional cardiac risks are present - History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of long QT syndrome - Participants who have been diagnosed with Stage IV breast cancer or inflammatory breast cancer - Please, review the protocol for more details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IDFS is defined as the time from randomization to first occurrence of one of the following IDFS events - Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion) - Ipsilateral locoregional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast) - Distant recurrence (i.e., evidence of breast cancer in any anatomic site other than the two sites mentioned above that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer) - Contralateral invasive breast cancer - Death from any cause, including breast cancer, non-breast cancer, or unknown cause (but the cause of death should be specified, if possible) - All second primary non-breast cancers and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancers will be excluded as an event for this endpoint. 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: 10 years (5 years for treatment and 5 years of follow-up after the treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| IDFS is defined as the time from randomization to first occurrence of one of the following IDFS events - Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion) - Ipsilateral locoregional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast) - Distant recurrence (i.e., evidence of breast cancer in any anatomic site other than the two sites mentioned above that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer) - Contralateral invasive breast cancer - Death from any cause, including breast cancer, non-breast cancer, or unknown cause (but the cause of death should be specified, if possible) - All second primary non-breast cancers and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancers will be excluded as an event for this endpoint. 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: 10 years (5 years for treatment and 5 years of follow-up after the treatment);Overall survival, defined as the time from randomization to death from any cause NAME OF THE RESULT: Overall Survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Death from any cause;IDFS (per STEEP; Hudis et al. 2007), 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) NAME OF THE RESULT: IDFS PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 5 years after the treatment;DFS, defined as the time from randomization to first occurrence of an ID | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Korea South, Lithuania, Macedonia, Malasya, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Uganda, Ukraine, United Kindgdom, United States, Vietnam
Contacts
Public ContactJUANITA ACHING
ROCHE FARMA (PERU) S.A.
Outcome results
None listed