Allegheny Health Network
Find a
Doctor
Request An Appointment Login to
MyChart
Patient
Center
News Classes &
Events
Contact
Us
Call 412.Doctors

Active Clinical Trials

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC (CapItello290)

Active NCT: 03997123
Allegheny General Hospital
Allegheny General Hospital

Forbes Hospital
Forbes Hospital

Category:
Cancer - Breast
Sponsor: 
AstraZeneca
Contact: 

For more information about this trial, please call 412-330-6151 or send an email to ClinicalTrials@ahn.org.

AZ TNBC – CAPITELLO, D3614C00001, A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC)

Purpose: 

Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

Ages Eligible for Study:  18 Years to 130 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

Histologically confirmed TNBC from most recently collected tumour tissue sample

Metastatic or locally recurrent disease; locally recurrent disease most not be amenable to resection with curative intent (patient who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible)

ECOG/WHO PS: 0-1

Measurable disease according to RECIST 1.1 and/or lytics or mixedbone lesions that can be assessed by CT or MRI in the absence of measurable disease

FFPE tumour sample from primary/recurrent cancer

Exclusion Criteria:

Prior chemotherapy in the (neo)adjuvant setting within 12 months from the end of chemotherapy to inclusion into this study

Prior systematic therapy for inoperable locally advanced or metastatic disease

Prior treatment with any of the following:

AKT, PI3K, and/or mTOR inhibitors

Capivasertib in the present study (ie, any dosing with capivasertib due to previous participation in this study)

Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long halflife (eg, biologics) as agreed by the sponsor

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 sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week prior to the first dose of study treatment.

Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)

Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5

With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment

Any of the following cardiac criteria at screening:

Mean resting corrected QT interval (QTc) >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 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 - SBP <90 mmHg and/or DBP <50 mmHg

Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiplegated 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 at screening:

Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment

HbA1c ≥8.0% (63.9 mmol/mol)

Inadequate bone marrow reserve or organ function at screening

Currently pregnant (confirmed with positive pregnancy test) or breast-feeding