HER2-negative Metastatic Breast CancerPhase 3DETECT IIINCT01619111
DETECT III - A Multicenter, Phase III Study to Compare Standard Therapy +/- Lapatinib in HER2-ve MBC-Patients With HER2+ve CTCs
A Phase 3 study testing standard chemo- or endocrine therapy and standard chemo- or endocrine therapy + Lapatinib in people with HER2-negative Metastatic Breast Cancer and HER2-positive Circulating Tumor Cells, run by Prof. Wolfgang Janni at 1 site in Germany.
Trial summary
The HER2 status in breast cancer patients may change during the course of the disease. In 30% of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive CTCs can be detected in peripheral blood samples(1). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-negative Metastatic Breast Cancer, HER2-positive Circulating Tumor Cells
- What is being tested?
- standard chemo- or endocrine therapy and standard chemo- or endocrine therapy + Lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Jan 2022
- Phase
- Phase 3
- 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
- Written informed consent in study participation.
- Metastatic breast cancer which cannot be treated by surgery or radiotherapy only. The primary tumor and/or biopsies from metastatic sites or locoregional recurrences must have been confirmed as cancer by histopathology. Estrogen Receptor (EG) and Progesterone Receptor (PgR) status must have been documented.
- Primary tumor tissue and/or biopsies from metastatic sites or locoregional recurrences were investigated for HER2 status and all of the investigations showed HER2-negativity (i.e.: immunohistochemistry (IHC) score 0-1+ or 2+ and fluorescent in situ hybridization (FISH) negative or just FISH negative, whichever was performed).
- Evidence of HER2-positive CTCs. Evidence is assumed if the following holds:
- At least one CTC could be extracted from 7.5 ml patient blood by means of the CellSearch® Circulating Tumor Cell Kit (Veridex LLC) and
- At least one of all extracted CTCs was found to be HER2-positive. HER2 status must be assessed by means of IHC or FISH.
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- Indication for a standard chemo- or endocrine therapy whose combination with lapatinib is either approved (see SPC of Tyverb® 250 mg tablets) or has been investigated in prior clinical trials (see tables of section 8.2.1.).
- Tumor evaluation has been performed within 6 weeks before randomization and results are available.
- Patients must have at least one lesion that can be accurately measured according to RECIST guideline version 1.1 [Eisenhauer 2009].
- Age ≥ 18 years.
- ECOG Score < 2
- Adequate organ function within 7 days before randomization, evidenced by the following laboratory results below:
- absolute neutrophil count ≥ 1500/µL,
- platelet count ≥ 100000/µL,
- hemoglobin ≥ 9 g/dL,
- ALT (SGPT) ≤ 2.5 × ULN,
- AST (SGOT) ≤ 2.5 × ULN,
- serum alkaline phosphatase ≤ 2.5 × ULN, (Serum alkaline phosphatase may be > 2.5 × ULN only if bone metastases are present and AST (SGOT) and ALT (SGPT) < 1.5× ULN)
- creatinine ≤ 2.0 mg/dl or 177µmol/L
- International normalized ratio (INR) and activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) ≤ 1.5 × ULN Please note: These laboratory criteria only refer to lapatinib therapy; with respect to the standard anticancer therapy the relevant summaries of product characteristics (SPCs) have to be observed additionally.
- Left ventricular cardiac ejection fraction (LVEF) ≥ 50%, in case of planned standard chemotherapy with anthracyclines ≥ 55%, and in any case within normal institutional limits as measured by echocardiogram
- In case of patients of child bearing potential:
- Negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to randomization,
- Contraception by means of a reliable method (i.e. non-hormonal contraception, IUD, a double barrier method, vasectomy of the sexual partner, complete sexual abstinence). Patient must consent in maintaining such contraception until 28 days after completion of study treatment.
Who cannot join
- History of hypersensitivity reactions attributed to compounds of similar chemical or biological composition to lapatinib.
- History of > 3 chemotherapy lines for metastatic disease (a chemotherapy line being defined as any new chemotherapy and any modification of an existing chemotherapy regimen regardless of the reason for change).
- Treatment with investigational agents of any type or anticancer therapy during the trial or within 4 weeks prior to randomization and 6 weeks in case of nitrosoureas or mitomycin C.
- Adverse events due to prior anticancer therapy which are > Grade 1 (NCI CTCAE) at time of randomization.
- Anti-retroviral therapy due to HIV infection.
- Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
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- 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 CIN of the uterine cervix and skin basalioma.
- Disease or condition which might restrain the ability to take or absorb oral medication. This includes malabsorption syndrome, requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption (for example resection of small bowel or stomach), uncontrolled inflammatory GI disease (e.g., Crohn's disease) and any other diseases significantly affecting gastrointestinal function as well as inability to swallow and retain oral medication for any other reason.
- Active cardiac disease, defined as:
- History of uncontrolled or symptomatic angina,
- history of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation,
- myocardial infarction less than 6 months from study entry,
- uncontrolled or symptomatic congestive heart failure,
- ejection fraction below the institutional normal limit,
- any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient.
- 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 patients.
- Pregnancy or nursing.
- Primary tumor or biopsies from metastatic sites or locoregional recurrences showing HER2-positivity.
- Any prior treatment with anti-HER2 directed therapy.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DETECT III - A Multicenter, Randomized, Phase III Study to Compare Standard Therapy Alone Versus Standard Therapy Plus Lapatinib in Patients With Initially HER2-negative Metastatic Breast Cancer and HER2-positive Circulating Tumor Cells
The HER2 status in breast cancer patients may change during the course of the disease. In 30% of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive CTCs can be detected in peripheral blood samples(1). At present, it is unclear if therapy based on the HER2 status of CTC offers a clinical benefit for these patients. The DETECT III - trial compares lapatinib, as HER2-targeted therapy in combination with standard therapy versus standard therapy alone in those patients, with initially HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells.
As one of the first interventional trials based on the assessment of CTC phenotypes, the DETECT III - trial aims to evaluate the efficacy of HER2-targeted therapy in patients with MBC and HER2-positive CTCs as well as the significance of CTC as an early predictive marker for treatment response.
- Being tested
- standard chemo- or endocrine therapy, standard chemo- or endocrine therapy + Lapatinib
- Keywords
- metastatic breast cancer, circulating tumor cells, lapatinib
- 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.
standard chemo- or endocrine therapyDrug
standard chemo- or endocrine therapy:
- Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin)
- Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane)
standard chemo- or endocrine therapy + LapatinibDrug
Lapatinib
+ standard chemo- or endocrine therapy:
- Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin)
- Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane)
| Study group | Role | What they receive |
|---|---|---|
| standard therapy | Active comparator | standard chemo- or endocrine therapy Receives: Drug: standard chemo- or endocrine therapy |
| standard therapy + lapatinib | Experimental | standard chemo- or endocrine therapy + lapatinib Receives: Drug: standard chemo- or endocrine therapy + Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC clearance rate
CTC clearance rate: Proportion of patients with at least one CTC detected in 7.5 ml of peripheral blood drawn before treatment that show no evidence of CTCs in the blood after treatment (CTC prevalence as assessed using the Cell-Search® System; Veridex LLC, Raritan, USA)
Measured: 8 - 12 weeks
Secondary outcomes (9)
Overall response rate
Rate of complete (CR) and partial responses (PR) in patients with whom target lesions were defined
Measured: 8-12 weeks
Clinical benefit rate
Rate of patients who were assessed PR or CR or who had stable disease (SD) for at least 6 months.
Measured: 8-12 weeks
Overall survival
Time from randomization until death of any cause
Measured: 4 weeks
Dynamic of CTC
Descriptive statistics of regular CTC counts
Measured: 8-12 weeks
Quality of life (QoL)
As assessed by evaluation of the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires.
Measured: 4 weeks
Safety and tolerability of lapatinib
Assessed by evaluation of adverse event (AE) reports.
Measured: 4 weeks
Intensity of pain
Measured by use of numeric rating scale (NRS)
Measured: 4 weeks
Progression free survival (PFS)
Time interval from randomization until progressive disease (PD) or death from any cause, whichever comes first
Measured: 8 - 12 weeks
Level of compliance to study protocol.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2022
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HER2-negative Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Wolfgang Janni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Wolfgang Janni, University of Ulm
- Investigators
- Tanja Fehm, MD, PhD, Principal investigator, Heinrich-Heine University, DuesseldorfWolfgang Janni, MD, PhD, Study director, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619111
- Sponsor's protocol ID
- DETECT III
- Other IDs
- 2010-024238-46
- Acronym
- DETECT III
- Status last verified
- Jun 2024
- First submitted
- 30 May 2012
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fehm T, Muller V, Aktas B, Janni W, Schneeweiss A, Stickeler E, Lattrich C, Lohberg CR, Solomayer E, Rack B, Riethdorf S, Klein C, Schindlbeck C, Brocker K, Kasimir-Bauer S, Wallwiener D, Pantel K. HER2 status of circulating tumor cells in patients with metastatic breast cancer: a prospective, multicenter trial. Breast Cancer Res Treat. 2010 Nov;124(2):403-12. doi: 10.1007/s10549-010-1163-x. Epub 2010 Sep 22.
PubMed 20859679Fehm T, Mueller V, Banys-Paluchowski M, Fasching PA, Friedl TWP, Hartkopf A, Huober J, Loehberg C, Rack B, Riethdorf S, Schneeweiss A, Wallwiener D, Meier-Stiegen F, Krawczyk N, Jaeger B, Reinhardt F, Hoffmann O, Mueller L, Wimberger P, Ruckhaeberle E, Blohmer JU, Cieslik JP, Franken A, Niederacher D, Neubauer H, Pantel K, Janni W; DETECT Study Group. Efficacy of Lapatinib in Patients with HER2-Negative Metastatic Breast Cancer and HER2-Positive Circulating Tumor Cells-The DETECT III Clinical Trial. Clin Chem. 2024 Jan 4;70(1):307-318. doi: 10.1093/clinchem/hvad144.
PubMed 38175595
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DETECT III - A Multicenter, Randomized, Phase III Study to Compare Standard Therapy Alone Versus Standard Therapy Plus Lapatinib in Patients With Initially HER2-negative Metastatic Breast Cancer and HER2-positive Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT01619111
- Acronym / sponsor ID
- DETECT III / DETECT III
- Keywords
- metastatic breast cancer, circulating tumor cells, lapatinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Prof. Wolfgang JanniUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 14 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The HER2 status in breast cancer patients may change during the course of the disease. In 30% of initially HER2-negative patients with circulating tumor cells (CTC), HER2-positive CTCs can be detected in peripheral blood samples(1). At present, it is unclear if therapy based on the HER2 status of CTC offers a clinical benefit for these patients. The DETECT III - trial compares lapatinib, as HER2-targeted therapy in combination with standard therapy versus standard therapy alone in those patients, with initially HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells.
As one of the first interventional trials based on the assessment of CTC phenotypes, the DETECT III - trial aims to evaluate the efficacy of HER2-targeted therapy in patients with MBC and HER2-positive CTCs as well as the significance of CTC as an early predictive marker for treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard therapy | Active comparator | Drug: standard chemo- or endocrine therapystandard chemo- or endocrine therapy |
| standard therapy + lapatinib | Experimental | Drug: standard chemo- or endocrine therapy + Lapatinibstandard chemo- or endocrine therapy + lapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Written informed consent in study participation.
- Metastatic breast cancer which cannot be treated by surgery or radiotherapy only. The primary tumor and/or biopsies from metastatic sites or locoregional recurrences must have been confirmed as cancer by histopathology. Estrogen Receptor (EG) and Progesterone Receptor (PgR) status must have been documented.
- Primary tumor tissue and/or biopsies from metastatic sites or locoregional recurrences were investigated for HER2 status and all of the investigations showed HER2-negativity (i.e.: immunohistochemistry (IHC) score 0-1+ or 2+ and fluorescent in situ hybridization (FISH) negative or just FISH negative, whichever was performed).
- Evidence of HER2-positive CTCs. Evidence is assumed if the following holds:
- Indication for a standard chemo- or endocrine therapy whose combination with lapatinib is either approved (see SPC of Tyverb® 250 mg tablets) or has been investigated in prior clinical trials (see tables of section 8.2.1.).
Key exclusion criteria (23 listed)
- History of hypersensitivity reactions attributed to compounds of similar chemical or biological composition to lapatinib.
- History of > 3 chemotherapy lines for metastatic disease (a chemotherapy line being defined as any new chemotherapy and any modification of an existing chemotherapy regimen regardless of the reason for change).
- Treatment with investigational agents of any type or anticancer therapy during the trial or within 4 weeks prior to randomization and 6 weeks in case of nitrosoureas or mitomycin C.
- Adverse events due to prior anticancer therapy which are > Grade 1 (NCI CTCAE) at time of randomization.
- Anti-retroviral therapy due to HIV infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard chemo- or endocrine therapystandard chemo- or endocrine therapy: * Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin) * Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane) | Drug | standard therapy |
| standard chemo- or endocrine therapy + LapatinibLapatinib + standard chemo- or endocrine therapy: * Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin) * Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane) | Drug | standard therapy + lapatinib |
Primary outcome
CTC clearance rate
Time frame: 8 - 12 weeks
CTC clearance rate: Proportion of patients with at least one CTC detected in 7.5 ml of peripheral blood drawn before treatment that show no evidence of CTCs in the blood after treatment (CTC prevalence as assessed using the Cell-Search® System; Veridex LLC, Raritan, USA)
9 secondary outcomes
Overall response rate
Time frame: 8-12 weeks
Clinical benefit rate
Time frame: 8-12 weeks
Overall survival
Time frame: 4 weeks
Dynamic of CTC
Time frame: 8-12 weeks
Quality of life (QoL)
Time frame: 4 weeks
Safety and tolerability of lapatinib
Time frame: 4 weeks
Intensity of pain
Time frame: 4 weeks
Progression free survival (PFS)
Time frame: 8 - 12 weeks
Level of compliance to study protocol.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 20859679Fehm T, Muller V, Aktas B, Janni W, Schneeweiss A, Stickeler E, Lattrich C, Lohberg CR, Solomayer E, Rack B, Riethdorf S, Klein C, Schindlbeck C, Brocker K, Kasimir-Bauer S, Wallwiener D, Pantel K. HER2 status of circulating tumor cells in patients with metastatic breast cancer: a prospective, multicenter trial. Breast Cancer Res Treat. 2010 Nov;124(2):403-12. doi: 10.1007/s10549-010-1163-x. Epub 2010 Sep 22.
- Derived from this study: PubMed 38175595Fehm T, Mueller V, Banys-Paluchowski M, Fasching PA, Friedl TWP, Hartkopf A, Huober J, Loehberg C, Rack B, Riethdorf S, Schneeweiss A, Wallwiener D, Meier-Stiegen F, Krawczyk N, Jaeger B, Reinhardt F, Hoffmann O, Mueller L, Wimberger P, Ruckhaeberle E, Blohmer JU, Cieslik JP, Franken A, Niederacher D, Neubauer H, Pantel K, Janni W; DETECT Study Group. Efficacy of Lapatinib in Patients with HER2-Negative Metastatic Breast Cancer and HER2-Positive Circulating Tumor Cells-The DETECT III Clinical Trial. Clin Chem. 2024 Jan 4;70(1):307-318. doi: 10.1093/clinchem/hvad144.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Fehm, MD, PhD principal investigator
Heinrich-Heine University, Duesseldorf
Wolfgang Janni, MD, PhD study director
University Hospital Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing standard chemo- or endocrine therapy and standard chemo- or endocrine therapy + Lapatinib in people with HER2-negative Metastatic Breast Cancer and HER2-positive 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 24 inclusion and 23 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
CTC clearance rate (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 NCT01619111, which also lists 2 linked publications.
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.