Trial 1
|
Locally investigator-assessed progression-free survival
|
10
|
6
|
3 [2–unranked]
|
9
|
Overall survival
|
1 [1–unranked]
|
HCPs
|
|
7
|
|
4 [3–unranked]
|
6
|
Overall survival
|
1 [1–unranked]
|
Patients
|
|
3
|
|
2 [2–2]
|
3
|
Overall survival
|
1 [1–2]
|
|
|
|
|
|
|
|
|
Trial 2
|
Survival without distant metastasis at 5 years (time from trial randomisation until the first distant metastatic recurrence, or death from any cause).
|
11
|
4
|
3 [1–5]
|
11
|
- Overall survival (time from trial randomisation until death from any cause)
- Disease-free survival (time from trial randomisation until first disease progression or death from any cause).
|
2 [1–5]
2 [1–5]
|
HCPs
|
|
8
|
|
3.5 [1–5]
|
8
|
Overall survival (time from trial randomisation until death from any cause).
|
2 [1–5]
|
Patients
|
|
3
|
|
2 [1–3]
|
3
|
Disease-free survival (time from trial randomisation until first disease progression or death from any cause).
|
1 [1–2]
|
|
|
|
|
|
|
|
|
Trial 3
|
Invasive disease-free survival at 2-year follow-up. Defined as the time from randomisation to any of the following: invasive tumour recurrence (same side as original tumour), invasive breast cancer (opposite side), local or wider invasive recurrence, more distant recurrence, death from any cause
|
10
|
7
|
2.5 [1–unranked]
|
4
|
Overall survival (time from randomisation to death).
|
2 [1–unranked]
|
HCPs
|
|
7
|
|
3 [2–unranked]
|
6
|
Overall survival (time from randomisation to death)
|
2 [1–5]
|
Patients
|
|
3
|
|
1 [1–unranked]
|
1
|
- Invasive disease-free survival at 2-year follow-up. Defined as the time from randomisation to any of the following: invasive tumour recurrence (same side as original tumour), invasive breast cancer (opposite side), local or wider invasive recurrence, more distant recurrence, death from any cause
- Cumulative incidence of central nervous system (CNS) cancer recurrences (time from randomisation to CNS recurrence as first distant recurrence).
- Safety
|
1 [1–unranked]
1 [1–unranked]
1 [1–unranked]
|
|
|
|
|
|
|
|
|
Trial 4
|
Overall survival (time from randomisation to death from any cause).
|
9
|
4
|
2 [1–5]
|
9
|
Health related quality of life
|
1 [1.5–unranked]
|
HCPs
|
|
6
|
|
2.5 [1–5]
|
6
|
Health related quality of life
|
1.5 [1–4]
|
Patients
|
|
3
|
|
1 [1–2]
|
3
|
Overall survival (time from randomisation to death from any cause)
|
1 [1–2]
|
|
|
|
|
|
|
|
|
Trial 5
|
Overall survival (time from randomisation to death from any cause).
|
9
|
5
|
2 [1–unranked]
|
6
|
Difference between treatment groups in the change in systolic automated office blood pressure from baseline to week 12
|
2 [1–7]
|
HCPs
|
|
6
|
|
1 [1–unranked]
|
5
|
Difference between treatment groups in the change in systolic automated office blood pressure from baseline to week 12
|
2 [1–5]
|
Patients
|
|
3
|
|
3 [3–unranked]
|
1
|
- Cumulative incidence of regional recurrence and distant metastasis (i.e. that has spread)
- Survival time
|
1 [1–1]
1 [1–2]
|
|
|
|
|
|
|
|
|
Trial 6
|
Breast cancer-free interval (time from randomisation to any breast cancer event censored for deaths)
|
9
|
12
|
3 [1–unranked]
|
7
|
- Vaginal symptoms (vaginal dryness and pain with intercourse)
- Disease-free survival (time to any recurrence excluding lobular carcinoma in situ, second primary cancer, and death from any cause)
- Quality-of-life
|
2 [1–unranked]
2 [1–unranked]
2 [2–5]
|
HCPs
|
|
6
|
|
3.5 [2–unranked]
|
4
|
Quality-of-life
|
2 [2–4]
|
Patients
|
|
3
|
|
2 [1–3]
|
3
|
- Vaginal symptoms (vaginal dryness and pain with intercourse)
- Disease-free survival (time to any recurrence excluding lobular carcinoma in situ, second primary cancer, and death from any cause)
- Contralateral breast cancer
- Osteoporotic fractures
- Vasomotor symptoms
- Sexual functioning
|
1 [1–unranked]
1 [1–2]
1 [1–unranked]
1 [1–unranked]
1 [1–unranked]
1 [1–unranked]
|
|
|
|
|
|
|
|
|
Trial 7
|
Pathological complete response of the primary tumour in the breast (absence of histological evidence of invasive tumour cells in the breast sample removed at surgery)
|
8
|
5
|
2 [1–5]
|
8
|
Disease-free survival (time from randomisation to disease recurrence, or death)
|
1 [1–unranked]
|
HCPs
|
|
5
|
|
2 [1–5]
|
5
|
Pathological complete response of the primary tumour in the breast (absence of histological evidence of invasive tumour cells in the breast sample removed at surgery).
|
2 [1–5]
|
Patients
|
|
3
|
|
2 [2–2]
|
5
|
Disease-free survival (time from randomisation to disease recurrence, or death).
|
1 [1–1]
|
|
|
|
|
|
|
|
|
Trial 8
|
Disease-free survival (time from randomisation to the date of one of the following (whichever came first): local recurrence, distant metastases - i.e. cancer that has spread, contralateral or ipsilateral breast tumor (excluding ductal carcinoma in situ - i.e. cancer that has not spread), second primary malignancy, death from any cause, loss to follow-up or end of study.
|
9
|
3
|
2 [1–4]
|
9
|
- Disease-free survival (time from randomisation to the date of one of the following (whichever came first): local recurrence, distant metastases - i.e. cancer that has spread, contralateral or ipsilateral breast tumor (excluding ductal carcinoma in situ - i.e. cancer that has not spread), second primary malignancy, death from any cause, loss to follow-up or end of study.
- Overall survival (time from randomisation to the date of death from any cause, loss to follow-up or the end of study).
|
2 [1–4]
2 [1–5]
|
HCPs
|
|
6
|
|
2 [1–4]
|
6
|
Overall survival (time from randomisation to the date of death from any cause, loss to follow-up or the end of study).
|
1.5 [1–5]
|
Patients
|
|
3
|
|
1 [1–2]
|
3
|
Disease-free survival (time from randomisation to the date of one of the following (whichever came first): local recurrence, distant metastases - i.e. cancer that has spread, contralateral or ipsilateral breast tumor (excluding ductal carcinoma in situ - i.e. cancer that has not spread), second primary malignancy, death from any cause, loss to follow-up or end of study.
|
1 [1–2]
|
|
|
|
|
|
|
|
|
Trial 9
|
Time-to-event analysis of the rate of survival free from invasive cancer (first event of recurrence of one of the following: ipsilateral breast tumour, local recurrence, regional recurrence, distant recurrence, contralateral second primary invasive cancer, second primary non-breast invasive cancer (excluding non-melanoma skin cancer), or death without evidence of recurrence).
|
8
|
4
|
3 [1–unranked]
|
7
|
- Overall survival rate (proportion of patients who did not die from any cause).
- Freedom from any recurrence (first recurrence of breast cancer at any site or death with recurrence).
|
2 [1–unranked]
2 [1–unranked]
|
HCPs
|
|
6
|
|
3 [1–unranked]
|
5
|
- Overall survival rate (proportion of patients who did not die from any cause).
- Freedom from any recurrence (first recurrence of breast cancer at any site or death with recurrence).
|
2 [1–unranked]
2 [1–unranked]
|
Patients
|
|
2
|
|
3 [3–3]
|
2
|
Freedom from any recurrence (first recurrence of breast cancer at any site or death with recurrence).
|
2 [2–2]
|
|
|
|
|
|
|
|
|
Trial 10
|
Progression-free survival (Determined based on Investigator's assessments according to response evaluation criteria in solid tumours, or surgery or radiotherapy for worsening of disease, or death from any cause).
|
8
|
10
|
2 [1–unranked]
|
7
|
- Clinical benefit rate (best overall response of complete response, partial response, or stable disease ≥24 weeks).
- Progression-free survival (Determined based on Investigator's assessments according to response evaluation criteria in solid tumours, or surgery or radiotherapy for worsening of disease, or death from any cause).
|
2 [1–unranked]
2 [1–unranked]
|
HCPs
|
|
5
|
|
2.5 [2–unranked]
|
4
|
Objective response rate (best overall response of either complete response or partial response in patients with measurable disease at baseline).
|
2 [1–unranked]
|
Patients
|
|
3
|
|
1 [1–2]
|
3
|
- Progression-free survival (Determined based on Investigator's assessments according to response evaluation criteria in solid tumours, or surgery or radiotherapy for worsening of disease, or death from any cause).
- Health-related quality of life.
|
1 [1–2]
1 [1–unranked]
|
|
|
|
|
|
|
|
|
Trial 11
|
All recurrence (development of histologically confirmed breast cancer both invasive and new or recurrent ductal carcinoma in situ (DCIS)).
|
9
|
8
|
1 [1–unranked]
|
7
|
All recurrence (development of histologically confirmed breast cancer both invasive and new or recurrent ductal carcinoma in situ (DCIS)).
|
1 [1–unranked]
|
HCPs
|
|
6
|
|
1.5 [1–unranked]
|
4
|
All recurrence (development of histologically confirmed breast cancer both invasive and new or recurrent ductal carcinoma in situ (DCIS)).
|
1.5 [1–unranked]
|
Patients
|
|
3
|
|
1 [1–1]
|
3
|
All recurrence (development of histologically confirmed breast cancer both invasive and new or recurrent ductal carcinoma in situ (DCIS)).
|
1 [1–1]
|
|
|
|
|
|
|
|
|
Trial 12
|
Overall survival (time from randomisation to death from any cause).
|
9
|
8
|
2 [1–5]
|
9
|
Progression-free survival (time from randomisation to disease progression or death from any cause).
|
1 [1–5]
|
HCPs
|
|
6
|
|
2 [1–5]
|
6
|
Progression-free survival (time from randomisation to disease progression or death from any cause).
|
1.5 [1–5]
|
Patients
|
|
3
|
|
2 [2–2]
|
3
|
Progression-free survival (time from randomisation to disease progression or death from any cause).
|
1 [1–1]
|
|
|
|
|
|
|
|
|
Trial 13: primary 1
|
Investigator-assessed progression-free survival (time from randomisation to first documented disease progression according to RECIST or death from any cause).
|
8
|
10
|
2.5 [1–unranked]
|
6
|
Overall survival (interval from randomisation to death from any cause).
|
1.5 [1–5]
|
HCPs
|
|
6
|
|
3 [2–unranked]
|
4
|
Overall survival (interval from randomisation to death from any cause).
|
1.5 [1–5]
|
Patients
|
|
2
|
|
1.5 [1–2]
|
2
|
- Investigator-assessed progression-free survival (time from randomisation to first documented disease progression according to RECIST or death from any cause).
- Overall survival (interval from randomisation to death from any cause).
|
1.5 [1–2]
1.5 [1–2]
|
|
|
|
|
|
|
|
|
Trial 13: primary 2
|
Overall survival (interval from randomisation to death from any cause).
|
8
|
10
|
1.5 [1–5]
|
8
|
Overall survival (interval from randomisation to death from any cause).
|
1.5 [1–5]
|
HCPs
|
|
6
|
|
1.5 [1–5]
|
6
|
Overall survival (interval from randomisation to death from any cause).
|
1.5 [1–5]
|
Patients
|
|
2
|
|
1.5 [1–2]
|
2
|
- Investigator-assessed progression-free survival (time from randomisation to first documented disease progression according to RECIST or death from any cause).
- Overall survival (interval from randomisation to death from any cause).
|
1.5 [1–2]
1.5 [1–2]
|
|
|
|
|
|
|
|
|
Trial 14
|
5-year disease-free survival (date of randomisation to: the date of first relapse, to the date of death in women dying without relapse, or to the date of censor in women alive and relapse-free).
|
8
|
7
|
1.5 [1–unranked]
|
4
|
10-year disease-free survival.
|
1 [1–unranked]
|
HCPs
|
|
6
|
|
3 [2–3]
|
5
|
10-year disease-free survival.
|
1 [1–unranked]
|
Patients
|
|
2
|
|
4 [3–7]
|
4
|
5-year disease-free survival (date of randomisation to: the date of first relapse, to the date of death in women dying without relapse, or to the date of censor in women alive and relapse-free).
|
1 [1–unranked]
|
|
|
|
|
|
|
|
|
Trial 15
|
Pathological complete response (absence of invasive breast cancer in the breast and axillary lymph nodes, after neoadjuvant chemotherapy).
|
8
|
4
|
2.5 [1–5]
|
8
|
Disease-free survival.
|
1 [1–unranked]
|
HCPs
|
|
6
|
|
2 [1–5]
|
6
|
Disease-free survival.
|
1.5 [1–unranked]
|
Patients
|
|
2
|
|
3 [3–3]
|
2
|
Disease-free survival.
|
1 [1–1]
|
|
|
|
|
|
|
|
|
Trial 16
|
Progression-free survival (time from trial randomisation until the first progression of the cancer, or death due to any cause, whichever occurred first).
|
8
|
9
|
2 [1–unranked]
|
7
|
- Overall survival (time from randomisation to the date of death due to any cause).
- Quality of life.
- Progression-free survival (time from trial randomisation until the first progression of the cancer, or death due to any cause, whichever occurred first).
- Clinical benefit (proportion of patients whose final response to treatment is judged to be a) complete response or b) partial response, or who have stable cancer for ≥24 weeks).
|
2 [1–unranked]
2 [1–unranked]
2 [1–unranked]
2 [1–unranked]
|
HCPs
|
|
6
|
|
2 [1–unranked]
|
5
|
- Overall survival (time from randomisation to the date of death due to any cause).
- Clinical benefit (proportion of patients whose final response to treatment is judged to be a) complete response or b) partial response, or who have stable cancer for ≥24 weeks).
|
1 [1–unranked]
1 [1–unranked]
|
Patients
|
|
2
|
|
2 [1–3]
|
2
|
- Overall survival (time from randomisation to the date of death due to any cause).
- Progression-free survival (time from trial randomisation until the first progression of the cancer, or death due to any cause, whichever occurred first).
|
2 [2–2]
2 [1–3]
|
|
|
|
|
|
|
|
|
Trial 17
|
Occurrence of any type of breast cancer (including ductal carcinoma in situ - i.e. cancer that has not spread).
|
8
|
4
|
1.5 [1–5]
|
8
|
Occurrence of any type of breast cancer (including ductal carcinoma in situ - i.e. cancer that has not spread).
|
1.5 [1–5]
|
HCPs
|
|
6
|
|
1.5 [1–5]
|
6
|
Occurrence of any type of breast cancer (including ductal carcinoma in situ - i.e. cancer that has not spread).
|
1.5 [1–5]
|
Patients
|
|
2
|
|
1.5 [1–2]
|
2
|
- Occurrence of any type of breast cancer (including ductal carcinoma in situ - i.e. cancer that has not spread).
- Occurrence of invasive oestrogen receptor-positive breast cancer.
|
1.5 [1–2]
1.5 [1–2]
|
|
|
|
|
|
|
|
|
Trial 18
|
Invasive disease–free survival (time from randomisation until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive breast cancer, contralateral invasive breast cancer, a distant disease recurrence, or death from any cause).
|
8
|
6
|
2 [1–unranked]
|
5
|
- Invasive disease–free survival (time from randomisation until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive breast cancer, contralateral invasive breast cancer, a distant disease recurrence, or death from any cause).
- Overall survival.
- Safety.
- Disease-free survival (including noninvasive breast cancers).
|
2 [1–unranked]
2 [1–unranked]
2 [2–unranked]
2 [1–unranked]
|
HCPs
|
|
6
|
|
2.5 [1–unranked]
|
4
|
Overall survival.
|
1 [1–5]
|
Patients
|
|
2
|
|
1 [1–1]
|
1
|
Invasive disease–free survival (time from randomisation until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive breast cancer, contralateral invasive breast cancer, a distant disease recurrence, or death from any cause).
|
1 [1–1]
|
|
|
|
|
|
|
|
|
Trial 19
|
Investigator-assessed progression-free survival (time from randomisation to radiologically confirmed disease progression according to RECIST, version 1.1, or death during the study).
|
7
|
8
|
2 [1–4]
|
7
|
- Clinical benefit response (defined as a confirmed complete response, a partial response, or stable disease for ≥24 weeks).
- Investigator-assessed progression-free survival (time from randomisation to radiologically confirmed disease progression according to RECIST, version 1.1, or death during the study).
|
2 [1–unranked]
2 [1–4]
|
HCPs
|
|
5
|
|
3 [1–4]
|
5
|
- Clinical benefit response (defined as a confirmed complete response, a partial response, or stable disease for ≥24 weeks).
- Overall survival objective response (defined as confirmed complete response or partial response).
- Patient-reported outcomes (assessed by health related quality-of-life scores).
|
2 [2–unranked]
2 [1–unranked]
2 [2–3]
|
Patients
|
|
2
|
|
1.5 [1–2]
|
2
|
Investigator-assessed progression-free survival (time from randomisation to radiologically confirmed disease progression according to RECIST, version 1.1, or death during the study).
|
1.5 [1–2]
|
|
|
|
|
|
|
|
|
Trial 20
|
Overall survival (time from randomisation to the date of death from any cause).
|
8
|
4
|
2 [1–unranked]
|
7
|
Disease-free survival (time from randomisation to the first date of local recurrence, regional recurrence, distant recurrence, second breast cancer, or death from any cause, whichever occurred first).
|
1 [1–unranked]
|
HCPs
|
|
6
|
|
2 [1–unranked]
|
5
|
- Disease-free survival (time from randomisation to the first date of local recurrence, regional recurrence, distant recurrence, second breast cancer, or death from any cause, whichever occurred first).
- Overall survival (time from randomisation to the date of death from any cause).
- Distant disease-free survival (time from randomisation to the first date of distant disease or death from any cause, whichever occurred first).
|
2 [1–unranked]
2 [1–unranked]
2 [1–5]
|
Patients
|
|
2
|
|
3.5 [3–4]
|
2
|
Disease-free survival (time from randomisation to the first date of local recurrence, regional recurrence, distant recurrence, second breast cancer, or death from any cause, whichever occurred first).
|
1 [1–1]
|