Breast Cancer Clinical Trial
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
Summary
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.
Full Description
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after aromatase inhibitor (AI) therapy.
Eligibility Criteria
Inclusion Criteria:
Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study
Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic), as per the American Society of Clinical Oncology and College of American Pathologists guideline recommendations. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.
Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
ECOG/WHO PS: 0-1
Patients are to have received treatment with an AI (aromatase inhibitor) containing regimen (single agent or in combination) and have:
Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an AI, OR
Radiological evidence of progression while on prior AI administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy)
Patients must have measurable disease according to RECIST 1.1 and/or at least 1 lytic or mixed (lytic + sclerotic) bone lesion that can be assessed by CT or MRI; patients with sclerotic/osteoblastic bone lesions only in the absence of measurable disease are not eligible
FFPE tumour sample from primary/recurrent cancer for central testing
Exclusion Criteria:
Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgement
More than 2 lines of endocrine therapy for inoperable locally advanced or metastatic disease
More than 1 line of chemotherapy for inoperable locally advanced or metastatic disease. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for advanced breast cancer
Prior treatment with any of the following:
AKT, PI3K and mTOR inhibitors
Fulvestrant, and other SERDs
Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation.
Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to study treatment initiation.
Radiotherapy with a wide field of radiation up to 4 weeks before study treatment initiation (capivasertib/placebo) and/or radiotherapy with a limited field of radiation for palliation up to 2 weeks before study treatment initiation (capivasertib/placebo)
With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids up to 4 weeks before study treatment initiation
Any of the following cardiac criteria:
Mean resting QT interval corrected by Fridericia's formula (QTcF) >470 msec obtained from 3 consecutive ECGs
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block)
Any factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥2
Uncontrolled hypotension - systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg
Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive)
Clinically significant abnormalities of glucose metabolism as defined by any of the following:
Patients with diabetes mellitus type 1 or diabetes mellitus type 2 requiring insulin treatment
HbA1c ≥8.0% (63.9 mmol/mol)
Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or LHRH agonist (if applicable)
Currently pregnant (confirmed with positive pregnancy test) or breast-feeding
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There are 210 Locations for this study
Gilbert Arizona, 85234, United States
Orange California, 92868, United States
San Francisco California, 94143, United States
Whittier California, 90603, United States
Fort Myers Florida, 33905, United States
Jacksonville Florida, 32224, United States
Westwood Kansas, 66205, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02111, United States
Rochester Minnesota, 55905, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63156, United States
Paramus New Jersey, 07652, United States
Farmington New Mexico, 87401, United States
Lake Success New York, 11042, United States
New York New York, 10011, United States
Greensboro North Carolina, 27403, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37211, United States
Dallas Texas, 75246, United States
Midlothian Virginia, 23114, United States
Puyallup Washington, 98373, United States
Berazategui , B1884, Argentina
Ciudad Autonoma De Buenos Aire , C1125, Argentina
La Rioja , 5300, Argentina
Rosario , S2000, Argentina
Viedma , R8500, Argentina
Adelaide , 5000, Australia
Ballarat , 3350, Australia
Birtinya , 4575, Australia
Box Hill , 3128, Australia
Concord , 2139, Australia
Kurralta Park , 5037, Australia
North Sydney , 2060, Australia
Orange , 2800, Australia
Ringwood East , 3135, Australia
South Brisbane , 4101, Australia
Waratah , 2298, Australia
Wendouree , 3355, Australia
Brussels , 1090, Belgium
Bruxelles , 1200, Belgium
Charleroi , 6000, Belgium
Edegem , 2650, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Winnipeg Manitoba, R3E 0, Canada
Kingston Ontario, K7L 2, Canada
North York Ontario, M2K 1, Canada
Toronto Ontario, M3M 0, Canada
Toronto Ontario, M4N 3, Canada
Baoding , 07100, China
Beijing , 10004, China
Beijing , 10019, China
Changchun , 13002, China
Chongqing , 40003, China
Chongqing , 40004, China
Dalian , 11601, China
Foshan , 52800, China
Gongshu District , 31002, China
Guangzhou , 51008, China
Guangzhou , 51009, China
Hangzhou , 31000, China
Hangzhou , 31002, China
Harbin , 15008, China
Hefei , 23000, China
Hefei , 23002, China
Jinan , 25000, China
Linyi , 27600, China
Nanchang , 33000, China
Nantong , 22600, China
Neijiang , 64100, China
Shanghai , 20003, China
Shanghai , 20012, China
Shantou , CN-51, China
Shenyang , 11000, China
Shenyang , 11004, China
Wuhan , 43002, China
Wuhan , 43003, China
Wuhan , 43007, China
Zhengzhou City , 45000, China
Besancon , 25000, France
Brest , 29609, France
Metz Cedex 03 , 57085, France
Pierre Benite CEDEX , 69310, France
Plerin SUR MER , 22190, France
Pringy , 74374, France
Rouen , 76038, France
STRASBOURG Cedex , 67065, France
Toulouse cedex 9 , 31059, France
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45130, Germany
Frankfurt , 60389, Germany
Gelsenkirchen , 45879, Germany
Hamburg , 20246, Germany
Hamburg , 20249, Germany
Hamburg , 20357, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Mannheim , 68167, Germany
Minden , 32429, Germany
Muenchen , 81377, Germany
München , 80637, Germany
Münster , 48149, Germany
Paderborn , 33161, Germany
Potsdam , 14467, Germany
Budapest , 1122, Hungary
Budapest , 1134, Hungary
Debrecen , 4032, Hungary
Kecskemét , 6000, Hungary
Szekszárd , 7100, Hungary
Szolnok , 5000, Hungary
Afula , 18341, Israel
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Kfar-Saba , 44281, Israel
Petah Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Bergamo , 24127, Italy
Candiolo , 10060, Italy
Catanzaro , 88100, Italy
Livorno , 57124, Italy
Macerata , 62100, Italy
Meldola , 47014, Italy
Milano , 20141, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Prato , 59100, Italy
Roma , 00128, Italy
Chiba-shi , 260-8, Japan
Fukuoka-shi , 811-1, Japan
Fukushima-shi , 960-1, Japan
Hidaka-shi , 350-1, Japan
Hiroshima-shi , 730-8, Japan
Kagoshima-shi , 892-0, Japan
Kitaadachi-gun , 362-0, Japan
Koto-ku , 135-8, Japan
Kumamoto-shi , 860-8, Japan
Kyoto-shi , 606-8, Japan
Matsuyama-shi , 791-0, Japan
Nagoya-shi , 464-8, Japan
Nagoya-shi , 467-0, Japan
Osaka-shi , 540-0, Japan
Osaka-shi , 541-8, Japan
Ota-shi , 373-8, Japan
Sapporo-shi , 003-0, Japan
Sapporo-shi , 060-8, Japan
Shinagawa-ku , 142-8, Japan
Tsu-shi , 514-8, Japan
Yokohama-shi , 241-8, Japan
Busan , 49241, Korea, Republic of
Daegu , 41931, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Incheon , 22332, Korea, Republic of
Seongnam-si , 13620, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 8308, Korea, Republic of
Suwon-si , 16247, Korea, Republic of
Suwon-si , 16499, Korea, Republic of
Arequipa , AREQU, Peru
Lima , LIMA , Peru
Bydgoszcz , 85-79, Poland
Krakow , 31-50, Poland
Olsztyn , 10-22, Poland
Warszawa , 02-78, Poland
Moscow , 11112, Russian Federation
Moscow , 11547, Russian Federation
Saint Petersburg , 19775, Russian Federation
Saint-Petersburg , 19825, Russian Federation
Samara , 44303, Russian Federation
Sochi , 35400, Russian Federation
A Coruña , 15009, Spain
Barcelona , 08035, Spain
Barcelona , 8003, Spain
Córdoba , 14004, Spain
Hosp de Llobregat(Barcelona) , 08907, Spain
Jaén , 23007, Spain
La Laguna (Tenerife) , 38320, Spain
Lérida , 25198, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Majadahonda , 28222, Spain
Malaga , 29010, Spain
Pamplona , 31008, Spain
Reus,Tarragona , 43204, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
Kaohsiung City , 82445, Taiwan
Taichung , 40447, Taiwan
Tainan City , 70403, Taiwan
Tainan , 710, Taiwan
Taipei , 10002, Taiwan
Taipei , 11217, Taiwan
Taipei , 11259, Taiwan
Taoyuan , 333, Taiwan
Aberdeen , AB25 , United Kingdom
Bournemouth , BH7 7, United Kingdom
Bristol , BS2 8, United Kingdom
Cardiff , CF14 , United Kingdom
Cheltenham , GL53 , United Kingdom
London , NW3 2, United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Sutton , SM25P, United Kingdom
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