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

NCT02035813 | Completed Phase 2 DMC

• 2 other identifiers: D-IV2013-001269-18
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer; HER2-negative Circulating Tumor Cells; Postmenopausal Female Patients

Keywords

metastatic breast cancer; circulating tumor cells; eribulin; ribociclib

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

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

  8-12 weeks

Secondary Outcomes (8)

• Overall response rate

  8-12 weeks

• Disease control rate (DCR)

  8-12 weeks

• Overall survival (OS)

  4 weeks

• Dynamic of CTCs

  8-12 weeks

• For Everolimus/Ribociclib cohort only: Levels of pS6

  8-12 weeks

Study Arms (2)

Ribociclib in combination with standard endocrine therapy

EXPERIMENTAL

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.

Drug: Ribociclib

Eriubulin

EXPERIMENTAL

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).

Drug: Eribulin

Interventions

Ribociclib DRUG

Ribociclib/Everolimus in combination with endocrine therapy

Also known as: Kisqali

Ribociclib in combination with standard endocrine therapy

Eribulin DRUG

Also known as: Halaven

Eriubulin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Prof. Wolfgang Janni: lead

Study Sites (1)

University Hospital Ulm -Department of Gynecology

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

ribociclib; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanja Fehm, MD, PhD

  University Hospital Düsseldorf -Department of Gynecology

  PRINCIPAL INVESTIGATOR

• Wolfgang Janni, MD, PhD

  University Hospital Ulm -Department of Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University hospital Ulm - Department of Gynecology

Study Record Dates

• First Submitted: January 12, 2014
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

DE (1)