AzTrials
AzTrials

HER2-negative and Hormone-receptor Positive Metastatic Breast CancerPhase 2NCT02035813

DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

A Phase 2 study testing Ribociclib and Eribulin in people with HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer and HER2-negative Circulating Tumor Cells, run by Prof. Wolfgang Janni at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ribociclib and Eribulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteGermany
Study dates
Jan 2014to 10 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 27Show fewer
  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Ulm -Department of Gynecology

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

About this study

Official title: 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.

Being tested
Ribociclib, Eribulin
Keywords
metastatic breast cancer, circulating tumor cells, eribulin, ribociclib
Medical subject headings
Breast Neoplasms, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibociclibDrug

    Also called Kisqali

    Ribociclib/Everolimus in combination with endocrine therapy

  • EribulinDrug

    Also called Halaven

Study groups in NCT02035813
Study groupRoleWhat they receive
Ribociclib in combination with standard endocrine therapyExperimentalPostmenopausal female patients with hormone-receptor positive, HER2-negative metastatic breast cancer with HER2-negative circulating tumor cells (CTCs) and indication for standard endocrine therapy.
Receives: Drug: Ribociclib
EriubulinExperimentalPatients 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).
Receives: Drug: Eribulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Time interval from randomization until progressive disease (PD) or death from any cause, whichever comes first

    Measured: 8-12 weeks

Secondary outcomes (8)

  1. Overall response rate

    Rate of complete (CR) and partial responses (PR) in patients with whom target lesions were defined

    Measured: 8-12 weeks

  2. Disease control rate (DCR)

    rate of patients who were assessed as having a PR or a CR or who had stable disease (SD) for at least 6 months

    Measured: 8-12 weeks

  3. Overall survival (OS)

    Time from randomization until death of any cause

    Measured: 4 weeks

  4. Dynamic of CTCs

    Descriptive statistics of regular CTC counts

    Measured: 8-12 weeks

  5. For Everolimus/Ribociclib cohort only: Levels of pS6

    Descriptive statistics of pS6 levels at baseline, at first radiological tumor assessment after about 12 weeks, and at the time of progression

    Measured: 8-12 weeks

  6. For Everolimus/Ribociclib cohort only: Change in the activation of the PI3K/Akt/mTOR-pathway in CTCs

    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)

    Measured: 8-12 weeks

  7. For Everolimus/Ribociclib cohort only: Estrogen-receptor 1 (ESR-1) mutations in CTCs

    Estrogen-receptor 1 (ESR-1) mutations in CTCs at baseline, after 12 weeks and at time of progression

    Measured: 8-12 weeks

  8. For Eribulin cohort only: New metastasis-free survival (nMFS)

    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

    Measured: 8-12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completion10 Jan 2024
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02035813
Sponsor's protocol ID
D-IV
Other IDs
2013-001269-18
Status last verified
Jun 2024
First submitted
12 Jan 2014
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Schochter F, Friedl TWP, Schaffler H, Meier-Stiegen F, Pfister KN, Riethdorf S, Wiesmuller L, Neubauer H, Muller L, Wimberger P, Fasching PA, Lorenz R, Hempel T, Heublein S, Hartkopf A, Pantel K, Rack B, Muller V, Fehm T, Janni W, Cieslik JP. Efficacy, safety and circulating tumor cell dynamics in patients treated with Eribulin for HER2-negative advanced breast cancer - results from the phase II DETECT IVb trial. Breast Cancer Res Treat. 2026 Sep 16;219(3):12. doi: 10.1007/s10549-026-08069-2.

    PubMed 42747616

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ribociclib and Eribulin in people with HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer and HER2-negative Circulating Tumor Cells, run by Prof. Wolfgang Janni at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02035813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in