Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Locally Advanced (Inoperable) or Metastatic Breast Cancer Clinical Trial

— CAPItello-292  

Official title:

A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862663
• Other study ID #: D361DC00001
• Secondary ID: 2020-004637-20
• Status: Recruiting
• Phase: Phase 3
• Start date: May 10, 2021
• Est. completion date: August 14, 2029

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Description:

This Phase Ib/III study (CAPItello-292) aims to evaluate the efficacy, safety and the degree of added benefit of capivasertib combined with CDK4/6i and fulvestrant in participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer. Although the dosing regimens of capivasertib + fulvestrant and of CDK4/6i + fulvestrant are established separately, the dose and schedule for the triplet combinations (capivasertib + CDK4/6i + fulvestrant) need to be confirmed. Therefore, the initial dose finding Phase Ib part of the study will determine the recommended Phase III doses (RP3D) of the triplet combinations. The Phase III part of the study will evaluate the efficacy, safety and the degree of added benefit of the triplet combinations of capivasertib and fulvestrant with investigator's choice of CDK4/6i (either palbociclib or ribociclib at safe and tolerable doses, once identified) in comparison with a control arm (fulvestrant + investigator's choice of CDK4/6i [palbociclib or ribociclib]) in a ER+ HER2- maC high risk population that did not receive prior endocrine therapy in the advanced setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 895
• Est. completion date: August 14, 2029
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Key inclusion criteria for both phases:

1. Adult females (pre-/peri-/ and post-menopausal), and adult males.

2. Histologically confirmed HR+/ HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.

3. Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4/6 inhibitors and dose levels required.

4. Adequate organ and bone marrow functions.

5. Consent to provide a mandatory FFPE tumour sample.

Key inclusion criteria only for phase III:

1. Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen.

2. Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA/AKT1/PTEN status.

3. Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4/6i options at time of enrolment), as per local investigator assessment.

4. Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed tomography (CT) or magnetic resonance imaging (MRI).

Key exclusion criteria for both phases:

1. History of another primary malignancy except for malignancy treated with curative intent with no known active disease = 2 years before the first dose of study intervention and of low potential risk for recurrence.

2. Radiotherapy within 2 weeks prior to study treatment initiation.

3. Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.

4. Persistent toxicities (CTCAE Grade >1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss or peripheral sensory neuropathy) after consultation with the AstraZeneca study physician.

5. Spinal cord compression, brain metastases or leptomeningeal metastases unless these lesions are definitively treated (eg. radiotherapy, surgery) and clinically stable off steroids for management of symptoms for at least 4 weeks prior to study treatment initiation.

6. Any of the following cardiac criteria at screening:

(a). Mean resting corrected QT interval (QTcF): (i) Participants to be treated with palbociclib:: QTcF = 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (ii) Participants to be treated with ribociclib: QTcF = 450 ms obtained from the average of 3 consecutive (triplicate) ECGs (iii) Participants to be treated with abemaciclib (Phase Ib only): QTcF = 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (b). Any clinically important abnormalities in cardiac rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) (c). Any factors that increase the risk of QTc prolongation or risk of arrhythmic events (d). Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure New York Heart Association (NYHA) grade = 2 (e). Uncontrolled hypotension (f) uncontrolled hypertension (g). Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher)

7. uncontrolled or high grade or symptomatic arrhythmia and atrial fibrillation

8. Any of these clinically significant abnormalities of glucose metabolism at screening:

1. . diabetes mellitus type I or type II requiring insulin treatment

2. . Glycated haemoglobin (HbA1c) = 8.0% (63.9 mmol/mol)

9. Previous allogeneic bone marrow transplant or solid organ transplant.

Key exclusion criteria for the phase III only:

1. Any prior treatment with, AKT, PI3K or mTOR inhibitors.

2. Prior treatment with CDK4/6 inhibitors in the metastatic setting (prior CDK4/6 inhibitors permitted in the adjuvant setting provided there was a CDK4/6i treatment free interval of at least 12 months).

3. More than 1 line of chemotherapy for metastatic disease

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced (Inoperable) or Metastatic Breast Cancer

Intervention

Drug:
• Capivasertib
Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion
• Fulvestrant
Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
• Palbociclib
Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg.
• Ribociclib
Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion.
• Abemaciclib
Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Chivilcoy
Argentina	Research Site	Rosario
Argentina	Research Site	Santa Fe
Australia	Research Site	Darlinghurst
Australia	Research Site	Miranda
Australia	Research Site	Nedlands
Australia	Research Site	Perth
Australia	Research Site	Wahroonga
Australia	Research Site	Waratah
Belgium	Research Site	Brasschaat
Belgium	Research Site	Bruxelles
Belgium	Research Site	Edegem
Belgium	Research Site	Haine-Saint-Paul
Belgium	Research Site	Leuven
Brazil	Research Site	Alfenas
Brazil	Research Site	Blumenau
Brazil	Research Site	Natal
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Velho
Brazil	Research Site	São Paulo
Brazil	Research Site	Taubaté
Brazil	Research Site	Teresina
Brazil	Research Site	Vitoria
Canada	Research Site	Abbotsford	British Columbia
Canada	Research Site	Brampton	Ontario
Canada	Research Site	Chicoutimi
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Montreal
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Sault Ste. Marie	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Bengbu
China	Research Site	Changchun
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Hefei
China	Research Site	Jinan
China	Research Site	Nanchang
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Nanning
China	Research Site	Shandong
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenyang
China	Research Site	Urumqi
China	Research Site	Urumqi
China	Research Site	Wuhan
China	Research Site	Xi'an
China	Research Site	Xian
China	Research Site	Xiangyang City
China	Research Site	Xuzhou
China	Research Site	Zhengzhou
Denmark	Research Site	Aalborg
Denmark	Research Site	Aarhus N
Denmark	Research Site	Hillerød
Denmark	Research Site	Odense C
France	Research Site	Bobigny
France	Research Site	Clermont Ferrand
France	Research Site	Limoges
France	Research Site	Lyon
France	Research Site	Plerin
France	Research Site	Rouen
France	Research Site	St Herblain
France	Research Site	Villejuif
Germany	Research Site	Augsburg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bottrop
Germany	Research Site	Dresden
Germany	Research Site	Erlangen
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Freiburg
Germany	Research Site	Georgsmarienhütte
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heilbronn
Germany	Research Site	Kiel
Germany	Research Site	Leipzig
Germany	Research Site	Mannheim
Germany	Research Site	Mönchengladbach
Germany	Research Site	Münster
Germany	Research Site	Regensburg
Germany	Research Site	Stade
Germany	Research Site	Trier
Germany	Research Site	Ulm
India	Research Site	Bangalore
India	Research Site	Jaipur
India	Research Site	JAipur
India	Research Site	Mohali
India	Research Site	Mysuru
India	Research Site	Nagpur
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	Pondicherry
India	Research Site	Vadodara
India	Research Site	Varanasi
Italy	Research Site	Milan
Italy	Research Site	Misterbianco
Japan	Research Site	Chuo-ku
Japan	Research Site	Koto-ku
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Malaysia	Research Site	George Town
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kuching
Malaysia	Research Site	Pulau Pinang
Malaysia	Research Site	Selangor
Malaysia	Research Site	Selangor
Poland	Research Site	Bydgoszcz
Poland	Research Site	Kraków
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Spain	Research Site	Barcelona
Spain	Research Site	Granada
Spain	Research Site	Lérida
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Pamplona
Spain	Research Site	Santiago de Compostela
Sweden	Research Site	Lund
Sweden	Research Site	Solna
Sweden	Research Site	Växjö
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Dusit
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Lampang
Thailand	Research Site	Ratchathewi
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Goztepe Istanbul
Turkey	Research Site	Karsiyaka
Turkey	Research Site	Kayseri
Turkey	Research Site	Malatya
Turkey	Research Site	Samsun
United Kingdom	Research Site	Derry
United Kingdom	Research Site	Guildford
United Kingdom	Research Site	London
United Kingdom	Research Site	Taunton
United Kingdom	Research Site	York
United States	Research Site	Annapolis	Maryland
United States	Research Site	Aurora	Colorado
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Boston	Massachusetts
United States	Research Site	Camden	New Jersey
United States	Research Site	Covington	Louisiana
United States	Research Site	Dallas	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Durham	North Carolina
United States	Research Site	Falls Church	Virginia
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Fort Worth	Texas
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Gresham	Oregon
United States	Research Site	Hannibal	Missouri
United States	Research Site	Houston	Texas
United States	Research Site	Leesburg	Virginia
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Louisville	Kentucky
United States	Research Site	Midlothian	Virginia
United States	Research Site	Midlothian	Virginia
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Newport Beach	California
United States	Research Site	Norfolk	Virginia
United States	Research Site	Omaha	Nebraska
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Providence	Rhode Island
United States	Research Site	Quincy	Illinois
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Francisco	California
United States	Research Site	Santa Barbara	California
United States	Research Site	Santa Rosa	California
United States	Research Site	Tacoma	Washington
United States	Research Site	Tucson	Arizona
United States	Research Site	York	Pennsylvania
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh city
Vietnam	Research Site	Ho Chi Minh city
Vietnam	Research Site	Vinh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  India,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Poland,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase Ib: 1. The number of participants with dose-limiting toxicity, as defined in the protocol.	Dose-limiting toxicity as described in the protocol that is not related to disease progression, intercurrent illness or concomitant medications and that, despite optimal therapeutic intervention, meets protocol-defined criteria.	Within the first 28 day cycle.
Primary	Phase Ib: 2. The number of participants with treatment-related adverse events.	Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of participants with treatment-related adverse events.	From baseline up to approximately 36 months.
Primary	Phase Ib: 3. The number of participants with treatment-related serious adverse events.	Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of participants with treatment-related adverse events.	From baseline up to approximately 36 months.
Primary	Phase III: 1. Progression Free Survival (PFS).	Progression Free Survival (PFS) is defined as time from randomization until progression per RECIST v1.1. as assessed by BICR or death due to any cause in the overall population, the altered population, and the confirmed non-altered population. RECIST related endpoints such as PFS, ORR, DoR, CBR will be collected.	Up to approximately 47 months.
Secondary	Phase Ib: 1. PK parameters for Palbociclib, Ribociclib, Abemaciclib: Cmax.	Maximum observed plasma (peak) drug concentration.	Cycle 0 (Cycle 0 is 3 days), Cycle 1 Day 11 and Cycle 1 Day 14 (Cycle 1 is 28 days).
Secondary	Phase Ib: 2. PK parameters for Palbociclib, Ribociclib, Abemaciclib: AUC0-72h.	Partial area under the plasma concentration-time curve from zero to 72 hours post-dose.	Cycle 0 (Cycle 0 is 3 days).
Secondary	Phase Ib: 3. PK parameters for Palbociclib, Ribociclib, Abemaciclib: AUC0-24h.	Partial area under the plasma concentration-time curve from zero to 24 hours post-dose.	Cycle 0 (Cycle 0 is 3 days), Cycle 1 Day 11 and Cycle 1 Day 14 (Cycle 1 is 28 days).
Secondary	Phase Ib: 4. PK parameters for Palbociclib, Ribociclib, Abemaciclib: Cmin.	Minimum observed plasma drug concentration.	Cycle 1 Day 11 and Cycle 1 Day 14 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary	Phase Ib: 5. PK parameters for capivasertib: Cmax.	Maximum observed plasma (peak) drug concentration.	Cycle 1 Day 11 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary	Phase Ib: 6. PK parameters for capivasertib: AUC0-12h.	Partial area under the plasma concentration-time curve from zero to 12 hours post-dose.	Cycle 1 Day 11 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary	Phase Ib: 7. PK parameters for capivasertib: Cmin.	Minimum observed plasma drug concentration.	Cycle 1 Day 11 (Cycle 0 is 3 days and Cycle 1 is 28 days).
Secondary	Phase Ib: 8. Objective Response Rate (ORR).	Objective Response Rate (ORR) is defined as the proportion of patients with measurable disease at baseline who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by the investigator at local site per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).	Up to approximately 36 months.
Secondary	Phase Ib: 9. Clinical Benefit Rate (CBR) at 24 weeks.	Clinical Benefit Rate (CBR) 24 weeks is defined as the percentage of patients who have a CR or PR or who have SD per RECIST v1.1 as assessed by the investigator at local site for at least 23 weeks after date of first dose.	Up to approximately 36 months.
Secondary	Phase Ib: 10. Duration of Response (DoR).	Duration of Response (DoR) will be defined as the time from the date of first documented confirmed response until date of documented progression per RECIST v1.1 as assessed by the investigator at local site or death due to any cause.	Up to approximately 36 months.
Secondary	Phase Ib: 11. Progression Free Survival (PFS).	Progression Free Survival (PFS) is defined as time from date of first dose until progression per RECIST v1.1. as assessed by the investigator at local site or death due to any cause.	Up to approximately 36 months.
Secondary	Phase III: 1. Overall Survival (OS).	Overall survival (OS) - time from randomization until the date of death due to any cause, secondary outcome measure in participants with HR+/HER2- locally advanced or metastatic breast cancer with gene alteration in PIK3CA/AKT1/PTEN - altered population, confirmed non-altered population and overall population.	Up to approximately 69 months.
Secondary	Phase III: 2. Objective Response Rate (ORR).	Objective Response Rate (ORR) - the proportion of patients who have a complete or partial response, as determined by BICR per RECIST v1.1 in participants with HR+/HER2- locally advanced or metastatic breast cancer with gene alteration in PIK3CA/AKT1/PTEN - altered population, confirmed non-altered population and overall population.	Up to approximately 47 months.
Secondary	Phase III: 3. Progression Free Survival 2 (PFS2)	Progression Free Survival 2 (PFS2) - time from randomization to the earliest of the progression event, after first subsequent therapy or death.	Up to approximately 69 months.
Secondary	Phase III: 4. Duration of Response (DoR).	Duration of Response (DoR) - the time from the date of first documented response until the date of progression per RECIST v1.1 as assessed by BICR, or death due to any cause.	Up to approximately 47 months.
Secondary	Phase III: 5. Clinical Benefit Rate (CBR) at 24 weeks.	Clinical Benefit Rate (CBR) at 24 weeks-the % of patients who have a CR or PR or who have SD per RECIST v1.1 as assessed by BICR for at least 23 weeks after randomisation.	Up to approximately 47 months.
Secondary	Phase III: 6. Participant-reported physical functioning	TTD of physical functioning as measured by the physical functioning subscale of the EORTC QLQ-C30.	Up to approximately 69 months.
Secondary	Phase III: 7. Participant-reported GHS/QoL in participants	TTD of GHS/QoL as measured by the GHS/QoL subscale of the EORTC QLQ-C30.	Up to approximately 69 months.
Secondary	Phase III: 8. Participant-reported overall side effect bother in participants in the capivasertib arm relative to control arm	Proportion of participants experiencing different levels of overall treatment tolerability as measured by the Patient Global Impression-Treatment Tolerability (PGI-TT).	Up to approximately 69 months.
Secondary	Phase III: 9. Plasma concentration of capivasertib pre- and post-dose.	Plasma concentration of capivasertib pre-, and post-dose.	Up to approximately 69 months.
Secondary	Phase III: 10. The number of participants with adverse events.	Data will include clinical observations, ECG parameters, clinical chemistry / haematology / glucose metabolism parameters and vital signs assessed as the number of participants with adverse events.	Up to approximately 69 months.
Secondary	Phase III: 11. The number of participants with serious adverse events.	Data will include clinical observations, ECG parameters, clinical chemistry / haematology / glucose metabolism parameters and vital signs assessed as the number of participants with serious adverse events.	Up to approximately 69 months.

External Links

•   BreastCancerStudyLocator.com