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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003798-85 | EudraCT Number |
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This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Giredestrant 10 mg | Experimental |
| |
| Giredestrant 30 mg | Experimental |
| |
| Giredestrant 100 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Giredestrant | Drug | Giredestrant will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the proportion of nuclei staining Ki67-positive (Ki67+) in the tumor biopsy sample taken post-treatment (at surgery) relative to that in the pre-treatment sample (at baseline). | Baseline and Surgery (Day 15) |
| Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the percentage of nuclei staining Ki67-positive (Ki67+) in the pre- and post-treatment tumor biopsy samples (taken at baseline and surgery, respectively) and the absolute difference in the percentage of Ki67+ nuclei between the two samples (calculated as surgery minus baseline). | Baseline and Surgery (Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | All adverse events (AEs) were recorded and the investigator independently assessed the seriousness and severity of each AE. AE severity was graded on a scale from 1 to 5 using the NCI-CTCAE v5.0; any events not specifically listed in the scale were defined as: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. Investigators used their knowledge of the patient, the circumstances surrounding the event, and an evaluation of any potential alternative causes to determine whether an AE was considered to be related to the study drug. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045-2517 | United States | ||
| Massachusetts General Hospital |
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).
For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Giredestrant 10 mg | Giredestrant 10 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2020 |
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| Surgery | Procedure | Breast cancer surgery will take place on Day 15 (+/-2 days). |
|
| From Baseline to Day 43 |
| Percentage of Participants With Abnormal Vital Signs During Treatment | Vital signs, which included diastolic and systolic blood pressure, pulse rate, and body temperature, were measured while the participant was sitting and according to institutional practices. Any of the vital signs that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). A vital sign result had to be reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. | Baseline, Days 1, 8, and 15 |
| Change From Baseline in Pulse Rate | Pulse rate was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
| Change From Baseline in Systolic Blood Pressure | Systolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
| Change From Baseline in Diastolic Blood Pressure | Diastolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
| Change From Baseline in Body Temperature | Body temperature was measured according to institutional practice. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
| Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Laboratory parameters for hematology will be measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. | Baseline, Days 1, 8, and 15 |
| Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Laboratory parameters for blood chemistry and coagulation were measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. SGPT/ALT = alanine aminotransferase; SGOT/AST = aspartate aminotransferase | Baseline, Days 1, 8, and 15 |
| Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | Electrocardiogram (ECG) recordings were performed after the participant had been resting in a supine position for at least 10 minutes. ECG parameters included heart rate, PR and QRS durations, and QT and QTcF intervals. Per the protocol, ECG readings post-treatment were limited to those for whom it was clinically indicated. Any of the ECG parameters that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). An ECG test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. | Baseline, Days 1, 8, and 15 |
| Plasma Concentration of Giredestrant at Steady State by Dose Level | Plasma samples were obtained on the day of surgery (Day 15), or prior to biopsy on Day 14. | Predose on day of surgery (Day 15), or prior to biopsy (Day 14) |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Sunshine Hospital | St Albans | Victoria | 3021 | Australia |
| Clinique Edith Cavell; Pharmacie | Auderghem | 1160 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| Clinique Sainte-Elisabeth; Oncologie | Namur | 5000 | Belgium |
| Onkologikoa - Instituto Oncológico de Donostia | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Ruber Internacional;Servicio de Oncologia | Madrid | 28034 | Spain |
| HM Sanchinarro ? CIOCC | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Barts Health NHS Trust; William Harvey Heart Centre, QMUL School of Medicine & Dentistry | London | EC1M 6BQ | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LQ | United Kingdom |
| FG001 |
| Giredestrant 30 mg |
Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| FG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
| Received at Least One Dose of Study Drug | Safety Evaluable Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
This is the Intent-to-Treat (ITT) Population, which includes all participants enrolled in the study regardless of whether they received any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Giredestrant 10 mg | Giredestrant 10 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| BG001 | Giredestrant 30 mg | Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| BG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was missing for one participant in the giredestrant 100 mg arm because of early withdrawal from the study. | Mean | Standard Deviation | Years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline | In order to enroll in the study, a participant was required to have an ECOG performance status ≤1; statuses of 0 and 1 are defined as follows: 0 = Fully active, able to carry on all pre-disease performance without restrictions; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework or office work). | ECOG performance status was missing for one participant in the giredestrant 100 mg arm because of early withdrawal from the study. | Count of Participants | Participants |
| |||||||||
| Initial Staging of Breast Cancer (Breast Cancer History) | The TNM description is used to assign an overall stage for breast cancer. There are 5 stages, usually written as Roman numerals: Stage 0 (in-situ breast cancer), followed by Stages I to IV (metastatic breast cancer). Generally, the higher the stage number, the more the cancer has spread. Stage I - the tumor is usually small and hasn't grown outside of the organ it started in. Stages II and III - the tumor is larger or has grown outside of the organ it started in to nearby tissue. | Count of Participants | Participants |
| ||||||||||
| Tumor Grade (Breast Cancer History) | The tumor grade is a description of how the cancer cells look compared to normal cells. A pathologist looks at a tissue sample from the tumor under a microscope and assigns a grade ranging from Grade 1 (low) to Grade 3 (high). The higher the grade, the more abnormal the cells look. Higher grade cancer cells tend to grow more quickly and are more likely to spread than low-grade cancer cells. | Count of Participants | Participants |
| ||||||||||
| Nodal Status (Breast Cancer History) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Tumor Cell Proliferation, as Measured by the Proportion of Nuclei Staining Ki67-Positive at Surgery Relative to Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the proportion of nuclei staining Ki67-positive (Ki67+) in the tumor biopsy sample taken post-treatment (at surgery) relative to that in the pre-treatment sample (at baseline). | Efficacy Evaluable Population: all participants who 1) had non-missing baseline and post-baseline Ki67 results available, 2) did not discontinue early from the study, 3) had taken at least 12 doses, and 4) had no more than one modified dose. A total of 10 participants (2 in the 10mg cohort, 5 in the 30mg cohort, and 3 in the 100mg cohort) were excluded from efficacy evaluation for not meeting the criteria. | Posted | Geometric Mean | 95% Confidence Interval | Proportion of Ki67+ nuclei | Baseline and Surgery (Day 15) |
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| Primary | Change From Baseline in Tumor Cell Proliferation, as Measured by the Difference in the Percentage of Nuclei Staining Ki67-Positive at Surgery Compared With Baseline in Pre- and Post-Treatment Tumor Biopsy Samples | The biological response to the study treatment was assessed by measuring changes in cell proliferation (Ki67 expression) using formalin-fixed paraffin-embedded histopathology sections of the tumor biopsy specimens taken at baseline and at day of surgery. Baseline was defined as a sample taken prior to initiation of study drug. The results show the percentage of nuclei staining Ki67-positive (Ki67+) in the pre- and post-treatment tumor biopsy samples (taken at baseline and surgery, respectively) and the absolute difference in the percentage of Ki67+ nuclei between the two samples (calculated as surgery minus baseline). | Efficacy Evaluable Population: all participants who 1) had non-missing baseline and post-baseline Ki67 results available, 2) did not discontinue early from the study, 3) had taken at least 12 doses, and 4) had no more than one modified dose. A total of 10 participants (2 in the 10mg cohort, 5 in the 30mg cohort, and 3 in the 100mg cohort) were excluded from efficacy evaluation for not meeting the criteria. | Posted | Mean | Standard Deviation | Percentage of nuclei Ki67+ | Baseline and Surgery (Day 15) |
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| Secondary | Number of Participants With at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) | All adverse events (AEs) were recorded and the investigator independently assessed the seriousness and severity of each AE. AE severity was graded on a scale from 1 to 5 using the NCI-CTCAE v5.0; any events not specifically listed in the scale were defined as: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening; and Grade 5 is death related to an AE. Investigators used their knowledge of the patient, the circumstances surrounding the event, and an evaluation of any potential alternative causes to determine whether an AE was considered to be related to the study drug. | Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. | Posted | Count of Participants | Participants | From Baseline to Day 43 |
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| Secondary | Percentage of Participants With Abnormal Vital Signs During Treatment | Vital signs, which included diastolic and systolic blood pressure, pulse rate, and body temperature, were measured while the participant was sitting and according to institutional practices. Any of the vital signs that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). A vital sign result had to be reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. | Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. | Posted | Number | Percentage of participants | Baseline, Days 1, 8, and 15 |
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| Secondary | Change From Baseline in Pulse Rate | Pulse rate was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
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| Secondary | Change From Baseline in Systolic Blood Pressure | Systolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint. | Posted | Mean | Standard Deviation | millimetres of mercury (mmHg) | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
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| Secondary | Change From Baseline in Diastolic Blood Pressure | Diastolic blood pressure was measured while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint. | Posted | Mean | Standard Deviation | millimetres of mercury (mmHg) | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
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| Secondary | Change From Baseline in Body Temperature | Body temperature was measured according to institutional practice. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit. Baseline was defined as the participant's last value prior to initiation of study drug. | Safety Evaluable Population: all participants who received at least one dose of giredestrant. One participant from the ITT population did not receive the study drug because of early withdrawal from the study. The number analyzed indicates all participants who had a non-missing assessment at a given timepoint. | Posted | Mean | Standard Deviation | degrees Celsius (C) | Baseline, Day 8, Surgery (Day 15), and Post-Surgery (Day 43) |
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| Secondary | Percentage of Participants With Laboratory Abnormalities in Hematology Tests During Treatment, Among Participants Without the Abnormality at Baseline | Laboratory parameters for hematology will be measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. | Safety Evaluable Population: the number of participants analyzed includes all participants who received at least one dose of giredestrant. The number analyzed for a given laboratory parameter represents the number of participants without an abnormality (in the specified direction) at baseline for that parameter. | Posted | Number | Percentage of participants | Baseline, Days 1, 8, and 15 |
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| Secondary | Percentage of Participants With Laboratory Abnormalities in Blood Chemistry and Coagulation Tests During Treatment, Among Participants Without the Abnormality at Baseline | Laboratory parameters for blood chemistry and coagulation were measured and compared with a standard reference range. Any of the laboratory test results that were outside of a parameter's normal reference range (in the specified direction - low or high) were considered abnormalities. Not every laboratory abnormality qualified as an adverse event (AE). A laboratory test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. SGPT/ALT = alanine aminotransferase; SGOT/AST = aspartate aminotransferase | Safety Evaluable Population: the number of participants analyzed includes all participants who received at least one dose of giredestrant. The number analyzed for a given laboratory parameter represents the number of participants without an abnormality (in the specified direction) at baseline for that parameter. | Posted | Number | Percentage of participants | Baseline, Days 1, 8, and 15 |
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| Secondary | Percentage of Participants With Abnormal Electrocardiogram Parameters During Treatment | Electrocardiogram (ECG) recordings were performed after the participant had been resting in a supine position for at least 10 minutes. ECG parameters included heart rate, PR and QRS durations, and QT and QTcF intervals. Per the protocol, ECG readings post-treatment were limited to those for whom it was clinically indicated. Any of the ECG parameters that were outside of the normal reference range (in the specified direction - low or high) were considered abnormalities. Not every abnormality qualified as an adverse event (AE). An ECG test result was reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment; resulted in a medical intervention or a change in concomitant therapy; or was clinically significant in the investigator's judgment. | The analysis included a small number of participants who had ECG readings post-treatment because, per the protocol, ECGs were limited to those for whom it was clinically indicated. | Posted | Number | Percentage of participants | Baseline, Days 1, 8, and 15 |
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| Secondary | Plasma Concentration of Giredestrant at Steady State by Dose Level | Plasma samples were obtained on the day of surgery (Day 15), or prior to biopsy on Day 14. | The Pharmacokinetics Analysis Population consisted of all participants who received at least one dose of giredestrant and had a measurable concentration at the specific timepoint collected. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per millilitre (ng/mL) | Predose on day of surgery (Day 15), or prior to biopsy (Day 14) |
|
From Baseline to Day 43
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Giredestrant 10 mg | Giredestrant 10 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. | 0 | 17 | 1 | 17 | 12 | 17 |
| EG001 | Giredestrant 30 mg | Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. | 0 | 40 | 2 | 40 | 21 | 40 |
| EG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. | 0 | 17 | 1 | 17 | 14 | 17 |
| EG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes a subset of the safety-evaluable participants who had ECG readings post-treatment because, per the protocol, ECGs were limited to those for whom it was clinically indicated. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. | 0 | 74 | 4 | 74 | 47 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast abscess | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA v24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Vitreous degeneration | Eye disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
| |
| Product dose omission in error | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA v24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Breast discomfort | Reproductive system and breast disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.0 | Systematic Assessment |
|
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but only after the first publication or presentation that involves the overall study. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 | genentech@druginfo.com |
| May 24, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720132 | giredestrant |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
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| OG001 | Giredestrant 30 mg | Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Efficacy: Giredestrant (10, 30, or 100 mg) | This analysis set includes all efficacy-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
| OG001 | Giredestrant 30 mg | Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety: Giredestrant (10, 30, or 100 mg) | This analysis set includes all safety-evaluable participants. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
Giredestrant 30 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG002 | Giredestrant 100 mg | Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
| OG003 | All Participants, Safety (ECG): Giredestrant (10, 30, or 100 mg) | This analysis set includes a subset of the safety-evaluable participants who had electrocardiogram (ECG) readings post-treatment because, per the protocol, ECGs were limited to those for whom it was clinically indicated. Participants in the three cohorts received giredestrant (10 mg, 30 mg, or 100 mg) that was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
|
|
Giredestrant 100 milligrams (mg) was administered orally once daily up to and including the day of surgery (if allowed per local process) on Day 15. Surgery should have been performed within 24 hours after the last dose of giredestrant. Following surgery, participants had a post-surgery follow-up visit after a period of 28 days. |
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