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Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer

ConditionCCCA Assessed by Ki67 Drop Below <2.7% From Baseline
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGBG Forschungs GmbH

About this trial

This is a multicenter, prospective, open-label, randomized phase II study to evaluate the CCCA assessed by Ki67 drop below \&lt;2.7% from baseline to week 2 (window of opportunity) and to week 10 with capivasertib plus fulvestrant compared with fulvestrant alone as neoadjuvant treatment for primary high-risk lobular breast cancer patients.

120 patients will be randomized to receive:

\- Capivasertib (400 mg po twice daily d1-4 followed by 3 days off) for 2 weeks followed by capivasertib (400 mg po twice daily d1-4 followed by 3 days off) and fulvestrant (500 mg i.m. q28d, with an additional 500 mg dose given two weeks after the initial dose) for additional 8 weeks (overall 4 administrations of fulvestrant)

or

\- Fulvestrant (500mg i.m. q28d, with an additional 500 mg dose given two weeks after the core biopsy and the initial dose) for 10 weeks (overall 4 administrations) Treatment will be given until surgery/core-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient.

All patients will undergo core-biopsies, under treatment and after completing study therapy in order to assess Ki67%. Further treatment including surgery, (neo)adjuvant chemotherapy, radiotherapy, and (neo)adjuvant endocrine therapy will be administered at the discretion of the investigator and according to standard of care outside the clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and followup, and documented according to the local regulatory requirements.

Postmenopausal women with age at diagnosis ≥ 18 years.

Age ≥60 years

Age <60 years and amenorrhea for at least 12 continuous months with no identified cause other than menopause

Disqualifiers

Female patients of childbearing potential.

Excisional biopsy or lumpectomy performed prior to study entry.

Surgical axillary staging procedure including sentinel lymph node biopsy prior to randomization. Exceptions: FNA or core biopsy of an axillary lymph node.

Any previous treatment including endocrine therapy, chemotherapy, radiotherapy or targeted therapy (including AKT inhibitor or PIK3 inhibitor) for the currently diagnosed breast cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capivasertib

    Drug

    find arm A description

  • Fulvestrant injection

    Drug

    find arm B description

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To assess complete cell cycle arrest (CCCA).

The primary endpoint CCCA is defined as Ki67 drop to \&lt;2.7% after approximately 10 weeks (will be assessed centrally on the breast tissue submitted to central pathology)

Time frame
Up to 14 weeks

Secondary outcomes

1

To asses safety and tolerability

Tolerability and safety analyses include assessment of patients whose treatment had to be dose reduced, delayed or permanently stopped.

Time frame
Up to 14 weeks
2

To assess patholgogical complete response rate (pCR) by different definitions

Pathological complete response (pCR ypT0 ypN0) is defined as no microscopic evidence of residual invasive and non-invasive viable tumor cells in all resected specimens of the breast and axilla.

Time frame
Up to 14 weeks
3

To assess breast conservation rate (BCS)

BCS is defiened as tumorectomy, segmentectomy or quandrantectomy as the most radical surgery.

Time frame
Up to 14 weeks
4

To assess invasive disease-free survival (iDFS) and overall survival (OS)

iDFS is defined as time from randomization until first iDFS event OS is defined as time from randomization until death due to any cause

Time frame
through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

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

GBG Forschungs GmbH

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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