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Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment

ConditionsBreast CancerHR-positive Breast CancerAdvanced Breast CancerMetastatic Breast CancerHER2-negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWomen's Cancer Study Group GmbH

About this trial

This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment.

The goal of this study is

1. To evaluate benefit of capivasertib regarding time to next treatment (TTNT1) - i.e., time "on treatment" with capivasertib. 2. To evaluate the benefits of patient reported outcome(PRO)-adherence regarding the deterioration of quality of life (DQoL)-free interval.

There is no active comparison group but a historical control group consisting of data of patients treated within the CAPItello-291-study..

Participants will take capivasertib accompanied by standard of care endocrine treatment and are asked to document ther quality of life on standardised questionnaires. Optionally, patients can use eHealth support via their own smart phones.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form

Histologically confirmed HR+/HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) as per WHO classification. 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).

Presence of one or more of the PIK3CA/AKT1/PTEN biomarkers, preferably determined in tumour tissue*

Disqualifiers

Absence of an alteration in the PIK3CA/AKT1/PTEN biomarkers

Previous enrolment in the present study

Participation in another clinical study with any investigational medicinal product and still on IMP treatment or have participated in an interventional study that remains blinded

A disease burden that makes the patient ineligible for endocrine-based therapy per the investigator's best judgement (e.g., symptomatic visceral disease that is potentially life threatening in the short-term)

Trial design

Design model

Single group

Treatments tested in this trial

  • Capivasertib

    Drug

    2x400 mg, peroral, for 4 days, followed by 3 days off treatment

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: CapivasertibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Superiority* of TTNT1 in patients receiving capivasertib compared to an evidence-based "standard TTNT1 curve" for patients without capivasertib.

* Statistical comparison by survival modelling of time on treatment including competing risks. * Standard curve is derived from placebo + fulvestrant arm of CAPItello-291 trial and corresponds to 17% remaining "on-treatment" at 12 months. * Stratification by eHealth support vs. no eHealth support

Time frame
Last-patient-in plus 12 months
2

Superiority* of PRO-adherence compared to non-adherence regarding TTDQoL (aka DQoL-free interval).

* The event DQoL is defined in terms of a 10-point drop of the FACT-G score compared to baseline. * A patient is classified here as "PRO-non-adherent" if she does not use CANKADO on 60 or more of the first 90 days, otherwise as "PRO-adherent".

Time frame
through study completion, after 170 total DQoL-events occurred

Secondary outcomes

1

Progression-free survival (PFS): defined by either: • evidence of disease progression as assessed by treating physician or • death

• To evaluate progression-free survival (PFS) from index date (CAPI initiation)

Time frame
From date of inclusion until the date of first documented progression, assessed up to 60 months
2

Overall survival (OS)

• To evaluate overall survival (OS) from index date

Time frame
From date of inclusion until the date of first documented progression, assessed up to 60 months
3

Superiority of eHealth support (and summary statistics) regarding TTDQoL compared to patients entering the trial without eHealth support.**

• To evaluate the impact of eHealth support (with or without PRO-adherence) compared to no eHealth support regarding the DQoL-free interval (TTDQoL as defined above)

Time frame
From date of inclusion until the date of first documented progression, assessed up to 60 months
4

Evaluation of prophylactic and reactive treatments for AESI management

• To characterise the management of AESIs

Time frame
Treatment start until end of study, assessed up to 60 months

Other outcomes

1

Adverse Events with Common Terminology Criteria for Adverse Events (CTCAE) version 5 grade 3 and 4

• AE with CTCAE v5 grade 3+4

Time frame
Treatment start until end of study, assessed up to 60 months
2

Adverse Events of Specila Interest (AESI)-rate

• AESI-rate

Time frame
Treatment start until end of study, assessed up to 60 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's Cancer Study Group GmbH

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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