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Metastatic Breast CancerPhase 3NCT02344472

Detect V / CHEVENDO (Chemo vs. Endo)

A Phase 3 study testing pertuzumab, Trastuzumab and Capecitabine in people with Metastatic Breast Cancer, run by Prof. Wolfgang Janni at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus Kisqali® (ribociclib) in patients with HER2 positive and hormone-receptor positive metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
pertuzumab, Trastuzumab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
271 participants
Where
1 siteGermany
Study dates
Sep 2015to 31 Jan 2025
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

  • Signed, written informed consent in study participation
  • The primary tumor and/or biopsies from metastatic sites or locoregional recurrences have been confirmed as HER2-positive (FISH-positive or IHC 3+) and hormone receptor positive breast cancer by histopathology according to local testing
  • Metastatic breast cancer or locally advanced BC, which cannot be treated by surgery or radiotherapy only
  • Pre- and postmenopausal women are allowed
  • No more than two prior chemotherapies for metastatic disease
  • No more than two prior anti-HER2 therapies for metastatic disease
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  • Pertuzumab retreatment is allowed if prior pertuzumab treatment was finished 12 months before
  • At least one measurable lesion assessable using standard techniques by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
  • Tumor evaluation according to RECIST version 1.1 has been performed within 4 weeks before randomization based on local assessment
  • Age ≥ 18 years
  • 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
  • Left ventricular cardiac ejection fraction (LVEF) ≥ 50% at baseline (as measured by echocardiogram)
  • ECOG Score ≤ 2
  • Adequate organ function within 14 days before randomization, evidenced by the following laboratory results below:
  • absolute neutrophil count ≥ 1500 cells/µL,
  • platelet count ≥ 100000 cells/µL,
  • hemoglobin ≥ 9 g/dL,
  • ALT (SGPT) ≤ 2.0 × ULN (≤ 3.0 × ULN in case of liver metastases)
  • AST (SGOT) ≤ 2.0 × ULN (≤ 3.0 × ULN in case of liver metastases)
  • bilirubin ≤ 1.5 × ULN (with the exception of Gilbert's syndrome)
  • creatinine ≤ 2.0 mg/dl or 177µmol/L INR ≤ 1,5
  • Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplemets before the first dose of study medication:
  • Sodium
  • Potassium
  • Total calcium
  • In case of patients of child bearing potential:
  • Negative serum pregnancy test at baseline (within 7 days prior to randomization) and agreement to remain abstinent (if it is in line with the preferred and usual lifestyle) or use single or combined non-hormonal contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study treatment

Who cannot join

  • Patients will be excluded from the study for any of the following reasons:
  • History of hypersensitivity reactions attributed to trastuzumab, pertuzumab, ribociclib or to other components of drug formulation
  • Mandatory need for cytostatic treatment at time of study entry based on clinical judgment and national/international treatment guidelines
  • Known CNS metastases
  • Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol
  • Progression on prior Pertuzumab therapy
Show all 28Show fewer
  • Treatment with Pertuzumab within the last 12 months
  • Prior treatment with any mTOR- or CDK4/6-inhibitor
  • Treatment with any other investigational agents during trial
  • Known hypersensitivity to lecithin (soya) or peanuts
  • Life expectancy < 6 months
  • Patients with pre-existing grade ≥2 peripheral neuropathy are excluded from taxane-based chemotherapy
  • History of serious cardiac disease, including but not confined to:
  • history of documented heart failure or systolic dysfunction (LVEF < 50%)
  • high-risk uncontrolled arrhythmias i.e., atrial tachycardia with a heart rate ≥100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block)
  • angina pectoris requiring anti-anginal medication
  • clinically significant valvular heart disease
  • evidence of transmural infarction on ECG
  • poorly controlled hypertension (e.g., systolic >180 mm Hg or diastolic >100 mm Hg)
  • any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
  • Dyspnea at rest or other diseases that require continuous oxygen therapy
  • Patients with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications
  • Patients with known infection with HIV, hepatitis B virus, or hepatitis C virus
  • Male patients
  • Pregnant, lactating or women of childbearing potential without a negative pregnancy test (serum) within 7 days prior to randomization, irrespective of the method of contraception used
  • Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
  • Participation in another clinical study within the 30 days before registration
  • Legal incapacity or limited legal capacity

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Ulm Gynecology/Obstetrics

    Ulm

Other trials in Germany

About this study

Official title: DETECT V / CHEVENDO A Multicenter, Randomized Phase III Study to Compare Chemo- Versus Endocrine Therapy in Combination With Dual HER2-targeted Therapy of Herceptin® (Trastuzumab) and Perjeta® (Pertuzumab) Plus Kisqali® (Ribociclib) in Patients With HER2 Positive and Hormone-receptor Positive Metastatic Breast Cancer.

Chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus Kisqali® (ribociclib) in patients with HER2 positive and hormone-receptor positive metastatic breast cancer.

Read the detailed description

Especially for diseases that are not curable such as metastatic breast cancer (MBC), the maintenance of quality of life is one of the main aims of treatments. Adverse events are well-known side effects of any cytostatic treatment and impact the patients' quality of life. Therefore, new treatment options are developed that should stop or at least slow down metastatic spread of cancer without causing negative side effects in terms of high-grade adverse events. For patients with hormone-receptor positive and HER2 positive MBC the combination of HER2-targeted therapy with endocrine therapy has already been proven to be an effective and in many cases valuable alternative to the combination of HER2-targeted therapy with chemotherapy. The high relevance of HER2-neu-targeted/endocrine treatment combinations derives from the fact that potential chemotherapy-related toxicity can be avoided, which in turn positively affects quality of life. Clinical trials suggest an additional benefit when a CDK4/6 inhibitor is added to the combination of endocrine therapy and anti HER2 treatment. DETECT V is a randomized phase III study comparing the safety and efficacy of trastuzumab plus pertuzumab and the CDK 4/6 inhibitor ribociclib in combination with either endocrine therapy or chemotherapy.

Being tested
pertuzumab, Trastuzumab, Capecitabine, Paclitaxel, Vinorelbine
Keywords
MBC, HER2, CTC, endocrine therapy, Pertuzumab, Trastuzumab, HER2 therapy, Ribociclib
Medical subject headings
Breast Neoplasms

What participants receive

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

  • pertuzumabDrug

    Also called Perjeta®

    HER2 targeted Therapy

  • TrastuzumabDrug

    Also called Herceptin®

    HER2 targeted Therapy

  • CapecitabineDrug

    Chemotherapy

  • PaclitaxelDrug

    Chemotherapy

  • VinorelbineDrug

    Chemotherapy

  • DocetaxelDrug

    Chemotherapy

  • ExemestaneDrug

    endocrine therapy

  • LetrozoleDrug

    endocrine therapy

  • AnastrozoleDrug

    endocrine therapy

  • FulvestrantDrug

    endocrine therapy

  • RibociclibDrug

    Also called Kisqali®

    CDK 4/6 inhibitor

  • nab-PaclitaxelDrug

    chemotherapy

  • eribulinDrug

    chemotherapy

  • leuprorelinDrug

    endocrine therapy

  • goserelinDrug

    endocrine therapy

Study groups in NCT02344472
Study groupRoleWhat they receive
Chemotherapy with docetaxelExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus docetaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Docetaxel
Chemotherapy with paclitaxelExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus paclitaxel.Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Paclitaxel
Chemotherapy with vinorelbineExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus vinorelbine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Vinorelbine
Chemotherapy with capecitabineExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus capecitabine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Capecitabine
endocrine therapy with exemestaneExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane.
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Exemestane; Drug: Ribociclib
endocrine therapy with fulvestrantExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant.
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Fulvestrant; Drug: Ribociclib
endocrine therapy with anastrozoleExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole.
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Anastrozole; Drug: Ribociclib
endocrine therapy with letrozoleExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole.
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Letrozole; Drug: Ribociclib
Chemotherapy with nab-PaclitaxelExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus nab-Paclitaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: nab-Paclitaxel
Chemotherapy with eribulinExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus eribulin. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib).
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: eribulin
endocrine therapy with leuprorelinExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin.
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Ribociclib; Drug: leuprorelin
endocrine therapy with goserelinExperimentaldual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin.
Receives: Drug: pertuzumab; Drug: Trastuzumab; Drug: Ribociclib; Drug: goserelin

What is being measured

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

  1. Number of Participants with Adverse Events

    safety of a dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (riobciclib) plus endocrine therapy as compared to a dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus chemotherapy (followed by endocrine therapy plus ribociclib in combination with trastuzumab and pertuzumab as maintenance therapy) by the proportion of patients experiencing any adverse event (as defined by the modified adverse event score)

    Measured: 3 - 9 weeks

Secondary outcomes (9)

  1. quality-adjusted survival

    to assess quality-adjusted survival (as assessed by the Q-TWiST method) and to compare it between the two treatment arms

    Measured: 3 - 9 weeks

  2. overall response rate (ORR)

    compare efficacy between the two treatment arms as assessed by overall response rate (ORR)

    Measured: 3 - 9 weeks

  3. incidence of central nervous system (CNS) metastases and their control rate

    assess the incidence of CNS metastases and control rate of preexisting CNS metastases

    Measured: 3 - 9 weeks

  4. Analysis of Quality of life

    assess additional aspects of quality of life based on the evaluation of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) QLQ-C30 and QLQ-BR23 questionnaires

    Measured: 3 - 9 weeks

  5. presence and number of circulating tumor cell (CTC) at different time points

    determine presence and number of CTC in the peripheral blood at baseline and at different time points after the start of palliative treatment including the time of progression, and to assess the value of CTCs as indicator for therapy success

    Measured: 6 weeks

  6. Evaluation of all reported events and all grades in both treatment arms (chemotherapy and endocrine therapy)

    All reported events with all grades for evaluation of safety and tolerability of the study treatments and to to evaluate and compare toxicity of chemotherapy arm vs. endocrine treatment arm

    Measured: 3 - 9 weeks

  7. disease control rate (DCR)

    compare efficacy between the two treatment arms as assessed by disease control rate (DCR)

    Measured: 3 - 9 weeks

  8. progression-free survival (PFS)

    compare efficacy between the two treatment arms as assessed by progression-free survival (PFS)

    Measured: 3 - 9 weeks

  9. overall survival (OS)

    compare efficacy between the two treatment arms as assessed by overall survival (OS)

    Measured: 3 - 9 weeks

Timeline

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

  1. First posted26 Jan 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2025 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
271 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02344472
Sponsor's protocol ID
D-V
Other IDs
2014-002249-22, 2014
Status last verified
Jun 2024
First submitted
11 Jan 2015
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pertuzumab, Trastuzumab and Capecitabine in people with Metastatic Breast Cancer, 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 29 inclusion and 28 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: status not confirmed, 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?

Results are not available in the source record.

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?

Number of Participants with Adverse Events (time frame: 3 - 9 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 NCT02344472.

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 last refreshed its copy on 31 Oct 2026.

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