- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02035813
DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
July 27, 2022 updated by: Prof. W. Janni
DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
Several studies have indicated that determining prevalence and number of circulating tumor cells (CTCs) at various time points during treatment may be an effective tool for assessing treatment efficacy in metastatic breast cancer (MBC).
However, even if the prognostic value of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in predicting treatment response needs further investigation.
DETECT IV is a prospective, multicenter, open-label, phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs).
Additional research on CTC dynamics and characteristics will provide a better understanding of the prognostic and predictive value of CTCs and is one step into a more personalized therapy for MBC.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Baden-Württemberg
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Ulm, Baden-Württemberg, Germany, 89075
- University Hospital Ulm -Department of Gynecology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Both cohorts:
- Indication for an endocrine therapy (Histological confirmation of estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) breast cancer).
- Up to two lines of previous cytostatic treatment for MBC.
- Any endocrine therapy in the history is allowed.
- Disease progression following prior treatment with endocrine therapy (endocrine therapy does not have to be the last therapy before inclusion in the trial).
Postmenopausal women. The investigator must confirm postmenopausal status Postmenopausal status is defined either by
- Age ≥ 55 years and one year or more of amenorrhea
- - Age < 55 years and one year or more of amenorrhea and postmenopausal levels of FSH and LH
- - Prior hysterectomy and has postmenopausal levels of FSH and LH
- - Surgical menopause with bilateral oophorectomy
- Everolimus cohort:
- Cholesterol ≤ 2.0 × ULN
- Ribociclib cohort:
- Standard 12-lead ECG values assessed by the local laboratory:
- - QTcF interval at screening < 450 msec (using Fridericia's correction)
- - Resting heart rate 50-90 bpm
- INR ≤ 1,5 (ribocilclib cohort)
- Patients must have the following laboratory values within normal limits or corrected to within normal lim-its with supplemets before the first dose of study medication:
- -Sodium
- -Potassium
- -Total calcium
For Eribulin only:
- Either hormone-receptor negative MBC or hormone-receptor positive MBC with indication for chemotherapy
- Up to three previous chemotherapy treatment lines for metastatic disease
In case of patients of child bearing potential:
- Negative pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 7 days prior to recruitment
- Contraception by means of a reliable method (i.e. non-hormonal contraception, IUD, a dou-ble barrier method, vasectomy of the sexual partner, complete sexual abstinence). Patient must consent in maintaining such contracep-tion until 3 months after completion of study treatment
Exclusion Criteria:
In General for both study cohorts:
- Treatment with other investigational agents of any type or anticancer therapy during the trial, within 2 weeks prior to the start of treatment.
- Adverse events due to prior anticancer therapy which are > Grade 1 (NCI CTCAE) and therapeutically relevant at time of treatment start.
- Known HIV infection.
- Current active hepatitis B or C, cliniclally relevant known liver dysfunction, e.g. according to Child Pugh Classifica-tion class B and C, or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gall-stones, liver metastases or stable chronic non-viral liver disease per investigator assessment).
- Concurrent disease or condition that might interfere with adequate assessment or evaluation of study data, or any medical disorder that would make the patient's participation unreasonably hazardous.
- Other malignant diseases within the last 3 years (apart from carcinoma in situ of the cervix or non-melanoma skin cancer)
- Dementia, altered mental status, or any psychiatric or social condition which would prohibit the understanding or rendering of informed consent or which might interfere with the patient's adherence to the protocol.
- Life expectancy < 3 months.
- Male gender.
For Everolimus/Ribociclib only:
- Known hypersensitivity to any of the excipients of ribociclib, everolimus or any of the other given drugs.
- Known hypersensitivity to lecithin (soya) and pea-nuts (ribocilib-cohort)
- Disease or condition, which might restrain the ability to take or resorb oral medication. This includes malabsorption syndrome, requirement for intrave-nous (IV) alimentation, prior surgical procedures af-fecting absorption (for example resection of small bowel or stomach), uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis) and any other diseases significantly affecting gas-trointestinal function as well as inability to swallow and retain oral medication for any other reason.
For Eribulin only:
- History of hypersensitivity reactions attributed to eribulin.
- Pre-existing neuropathy grade 3 or higher.
- Severe Congenital long QT syndrome.
- Pregnancy or nursing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ribociclib in combination with standard endocrine therapy
Postmenopausal female patients with hormone-receptor positive, HER2-negative metastatic breast cancer with HER2-negative circulating tumor cells (CTCs) and indication for standard endocrine therapy.
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Ribociclib/Everolimus in combination with endocrine therapy
Other Names:
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EXPERIMENTAL: Eriubulin
Patients with hormone-receptor positive, HER2-negative metastatic breast cancer and indication to chemother-apy or patients with triple-negative metastatic breast cancer, both with HER2-negative circulating tumor cells (CTCs).
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: 8-12 weeks
|
Time interval from randomization until progressive disease (PD) or death from any cause, whichever comes first
|
8-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: 8-12 weeks
|
Rate of complete (CR) and partial responses (PR) in patients with whom target lesions were defined
|
8-12 weeks
|
Disease control rate (DCR)
Time Frame: 8-12 weeks
|
rate of patients who were assessed as having a PR or a CR or who had stable disease (SD) for at least 6 months
|
8-12 weeks
|
Overall survival (OS)
Time Frame: 4 weeks
|
Time from randomization until death of any cause
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4 weeks
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Dynamic of CTCs
Time Frame: 8-12 weeks
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Descriptive statistics of regular CTC counts
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8-12 weeks
|
For Everolimus/Ribociclib cohort only: Levels of pS6
Time Frame: 8-12 weeks
|
Descriptive statistics of pS6 levels at baseline, at first radiological tumor assessment after about 12 weeks, and at the time of progression
|
8-12 weeks
|
For Everolimus/Ribociclib cohort only: Change in the activation of the PI3K/Akt/mTOR-pathway in CTCs
Time Frame: 8-12 weeks
|
Descriptive statistics of changes in the activation of the PI3K/Akt/mTOR-pathway in CTCs as assessed by longitudinal comparisons (at baseline, after 12 weeks, at time of progression)
|
8-12 weeks
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For Everolimus/Ribociclib cohort only: Estrogen-receptor 1 (ESR-1) mutations in CTCs
Time Frame: 8-12 weeks
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Estrogen-receptor 1 (ESR-1) mutations in CTCs at baseline, after 12 weeks and at time of progression
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8-12 weeks
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For Eribulin cohort only: New metastasis-free survival (nMFS)
Time Frame: 8-12 weeks
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New metastasis-free survival (nMFS), defined as time from recruitment to death or progression due to appearance of a new metastasis, whichever comes first.
If a patient has not had an event, nMFS is censored at the date of last adequate tumor as-sessment
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8-12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tanja Fehm, MD, PhD, University Hospital Düsseldorf -Department of Gynecology
- Study Director: Wolfgang Janni, MD, PhD, University Hospital Ulm -Department of Gynecology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ANTICIPATED)
December 1, 2024
Study Completion (ANTICIPATED)
December 1, 2024
Study Registration Dates
First Submitted
January 12, 2014
First Submitted That Met QC Criteria
January 13, 2014
First Posted (ESTIMATE)
January 14, 2014
Study Record Updates
Last Update Posted (ACTUAL)
July 28, 2022
Last Update Submitted That Met QC Criteria
July 27, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D-IV
- 2013-001269-18 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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