Captor-Bc: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut Für Frauengesundheit GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

13 Oct 2022 → ongoing

Decision date (initial)

2022-10-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novartis Pharma GmbH · Novartis Pharma GmbH

External identifiers

EU CT number

2022-500764-35-00

ClinicalTrials.gov

NCT05452213

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenomic, Safety, Efficacy

The co-primary objective of this trial are estimates for the survival rates of progression free survival (PFS) at months 12 and overall survival (OS) at months 12.

Secondary objectives 6

1. Progression-free survival rates at 18, 24 and 36 months
2. Overall survival rates at 18, 24 and 36 months
3. Median progression-free survival (if achieved at study end)
4. Median overall survival (if achieved at study end)
5. Health related quality of life FACT-G/FACT-B
6. Side effects assessed by NCI-CTCAE v.5.0

Conditions and MedDRA coding

Patients with advanced HER2-negative, hormone receptor positive (HER2neg/HR+) breast cancer in the first line therapeutic setting

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Indication for treatment with ribociclib in combination with endocrine therapy in the locally advanced or 1st line metastatic therapy setting according to SmPC. (Previous treatment with CDK4/6 inhibitors is allowed in the adjuvant setting)
2. Written informed consent prior to beginning of trial specific procedures
3. Subject must be female and aged ≥ 18 years on the day of signing informed consent
4. Locally advanced or metastatic breast cancer not amenable to curative treatment
5. Patient has HER2-negative breast cancer confirmed by local laboratory defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory
6. Histologically confirmed ER positive and/ or PgR positive breast cancer determined by core biopsy according to local in-house standard
7. QTcF interval < 450 ms
8. Adequate organ function amenable for treatment with ribociclib as assessed by local laboratory
9. Women of childbearing potential must have a negative urine or serum pregnancy test within 72 h prior to study entry and be willing to use highly effective method of contraception for course of the trial through 21 days after the last dose of trial treatment
10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures

Exclusion criteria 9

1. Concurrent participation in a study with an investigational agent/device or within 14 days of study entry or 5 half-lives of the respective investigational agent/device, whichever is longer
2. Patients who are not treated for advanced HRpos/HER2neg breast cancer in the first line therapy setting
3. Patients not eligible for treatment with ribociclib according to SmPC or investigator’s discretion
4. Patients who are pregnant or lactating
5. Patients with existing or patients who are at significant risk of developing QTc prolongation. This includes patients with long QT syndrome, uncontrolled or significant cardiac disease, including recent myocardial infarction, congestive heart failure, unstable angina and bradyarrhythmia, electrolyte abnormalities
6. Patients with known hypersensitivity to the active substance of ribociclib, soya, peanut or any other of the excipients of ribociclib
7. Patients with active systemic infections (for example, bacterial infection requiring intravenous antibiotics at time of initiating study treatment, fungal infection, or detectable viral infection requiring systemic therapy) or viral load (such as known human immunodeficiency virus positivity or with known active hepatitis B or C, for example, hepatitis B surface antigen positive)
8. Patients with serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (such as severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn’s disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea)
9. Patients who do not agree to collection of biospecimens samples (blood, stool, tissue)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. progression-free survival
2. overall survival

Secondary endpoints 4

1. progression-free survival
2. overall survival
3. health related quality of life FACT-G/FACT-B
4. occurence of side effects

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut Für Frauengesundheit GmbH

Sponsor organisation

Institut Für Frauengesundheit GmbH

Address

Hindenburgstrasse 50, Innenstadt Innenstadt

City

Erlangen

Postcode

91054

Country

Germany

Scientific contact point

Organisation

Institut Für Frauengesundheit GmbH

Contact name

Clinical Trial Team

Public contact point

Organisation

Institut Für Frauengesundheit GmbH

Contact name

Clinical Trial Team

Locations

1 EU/EEA country · 124 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications