Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC (CAPItello-290)

STATUS

Recruiting
End date

Oct 6, 2023
participants needed

924
sponsor

AstraZeneca

Send

Updated on 4 April 2023

See if I qualify

paclitaxel

cancer

measurable disease

breast cancer

triple-negative breast cancer

mammogram

formalin-fixed paraffin-embedded

Summary

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)

Description

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)

Details

Condition	Triple Negative Breast Neoplasms
Treatment	Placebo, Paclitaxel, Capivasertib
Clinical Study Identifier	NCT03997123
Sponsor	AstraZeneca
Last Modified on	4 April 2023

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
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 neoadjuvant or adjuvant setting within 6 months from the end of chemotherapy to the date of randomization; taxane chemotherapy in the neoadjuvant or adjuvant setting within 12 months from the end of chemotherapy to the start of randomization
	Prior systematic therapy for inoperable locally advanced or metastatic disease
	Prior treatment with any of the treatments listed below. Patients are not eligible to enter the study if they have received any of the medications specified below or are unable to meet the cautions and restrictions
	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 drugs that are sensitive to CYP3A4 inhibition 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)
	With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
	Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5
	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
	Uncontrolled hypotension - SBP <90 mmHg and/or DBP <50 mmHg
	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
	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)
	Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment
	Clinically significant abnormalities of glucose metabolism as defined by any of the
	following at screening
	Inadequate bone marrow reserve or organ function at screening
	Currently pregnant (confirmed with positive pregnancy test) or breast-feeding
	HbA1c ≥8.0% (63.9 mmol/mol)

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

triple-negative breast cancer

mammogram

formalin-fixed paraffin-embedded

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC (CAPItello-290)