search
Back to results

Detect V / CHEVENDO (Chemo vs. Endo)

Primary Purpose

Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
pertuzumab
Trastuzumab
Capecitabine
Paclitaxel
Vinorelbine
Docetaxel
Exemestane
Letrozole
Anastrozole
Fulvestrant
Ribociclib
nab-Paclitaxel
eribulin
leuprorelin
goserelin
Sponsored by
Prof. W. Janni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring MBC, HER2, CTC, endocrine therapy, Pertuzumab, Trastuzumab, HER2 therapy, Ribociclib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • 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
  • 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

Exclusion criteria:

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
  • 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

Sites / Locations

  • University Hospital Ulm Gynecology/ObstetricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Chemotherapy with docetaxel

Chemotherapy with paclitaxel

Chemotherapy with vinorelbine

Chemotherapy with capecitabine

endocrine therapy with exemestane

endocrine therapy with fulvestrant

endocrine therapy with anastrozole

endocrine therapy with letrozole

Chemotherapy with nab-Paclitaxel

Chemotherapy with eribulin

endocrine therapy with leuprorelin

endocrine therapy with goserelin

Arm Description

dual 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).

dual 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).

dual 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).

dual 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).

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane.

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant.

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole.

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole.

dual 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).

dual 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).

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin.

dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

quality-adjusted survival
to assess quality-adjusted survival (as assessed by the Q-TWiST method) and to compare it between the two treatment arms
overall response rate (ORR)
compare efficacy between the two treatment arms as assessed by overall response rate (ORR)
incidence of central nervous system (CNS) metastases and their control rate
assess the incidence of CNS metastases and control rate of preexisting CNS metastases
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
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
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
disease control rate (DCR)
compare efficacy between the two treatment arms as assessed by disease control rate (DCR)
progression-free survival (PFS)
compare efficacy between the two treatment arms as assessed by progression-free survival (PFS)
overall survival (OS)
compare efficacy between the two treatment arms as assessed by overall survival (OS)

Full Information

First Posted
January 11, 2015
Last Updated
July 27, 2022
Sponsor
Prof. W. Janni
Collaborators
Roche Pharma AG, Novartis Pharmaceuticals, Eisai GmbH, Celgene Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02344472
Brief Title
Detect V / CHEVENDO (Chemo vs. Endo)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. W. Janni
Collaborators
Roche Pharma AG, Novartis Pharmaceuticals, Eisai GmbH, Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
MBC, HER2, CTC, endocrine therapy, Pertuzumab, Trastuzumab, HER2 therapy, Ribociclib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy with docetaxel
Arm Type
Experimental
Arm Description
dual 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).
Arm Title
Chemotherapy with paclitaxel
Arm Type
Experimental
Arm Description
dual 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).
Arm Title
Chemotherapy with vinorelbine
Arm Type
Experimental
Arm Description
dual 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).
Arm Title
Chemotherapy with capecitabine
Arm Type
Experimental
Arm Description
dual 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).
Arm Title
endocrine therapy with exemestane
Arm Type
Experimental
Arm Description
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane.
Arm Title
endocrine therapy with fulvestrant
Arm Type
Experimental
Arm Description
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant.
Arm Title
endocrine therapy with anastrozole
Arm Type
Experimental
Arm Description
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole.
Arm Title
endocrine therapy with letrozole
Arm Type
Experimental
Arm Description
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole.
Arm Title
Chemotherapy with nab-Paclitaxel
Arm Type
Experimental
Arm Description
dual 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).
Arm Title
Chemotherapy with eribulin
Arm Type
Experimental
Arm Description
dual 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).
Arm Title
endocrine therapy with leuprorelin
Arm Type
Experimental
Arm Description
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin.
Arm Title
endocrine therapy with goserelin
Arm Type
Experimental
Arm Description
dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin.
Intervention Type
Drug
Intervention Name(s)
pertuzumab
Other Intervention Name(s)
Perjeta®
Intervention Description
HER2 targeted Therapy
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin®
Intervention Description
HER2 targeted Therapy
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
endocrine therapy
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
endocrine therapy
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Intervention Description
endocrine therapy
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
endocrine therapy
Intervention Type
Drug
Intervention Name(s)
Ribociclib
Other Intervention Name(s)
Kisqali®
Intervention Description
CDK 4/6 inhibitor
Intervention Type
Drug
Intervention Name(s)
nab-Paclitaxel
Intervention Description
chemotherapy
Intervention Type
Drug
Intervention Name(s)
eribulin
Intervention Description
chemotherapy
Intervention Type
Drug
Intervention Name(s)
leuprorelin
Intervention Description
endocrine therapy
Intervention Type
Drug
Intervention Name(s)
goserelin
Intervention Description
endocrine therapy
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
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)
Time Frame
3 - 9 weeks
Secondary Outcome Measure Information:
Title
quality-adjusted survival
Description
to assess quality-adjusted survival (as assessed by the Q-TWiST method) and to compare it between the two treatment arms
Time Frame
3 - 9 weeks
Title
overall response rate (ORR)
Description
compare efficacy between the two treatment arms as assessed by overall response rate (ORR)
Time Frame
3 - 9 weeks
Title
incidence of central nervous system (CNS) metastases and their control rate
Description
assess the incidence of CNS metastases and control rate of preexisting CNS metastases
Time Frame
3 - 9 weeks
Title
Analysis of Quality of life
Description
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
Time Frame
3 - 9 weeks
Title
presence and number of circulating tumor cell (CTC) at different time points
Description
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
Time Frame
6 weeks
Title
Evaluation of all reported events and all grades in both treatment arms (chemotherapy and endocrine therapy)
Description
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
Time Frame
3 - 9 weeks
Title
disease control rate (DCR)
Description
compare efficacy between the two treatment arms as assessed by disease control rate (DCR)
Time Frame
3 - 9 weeks
Title
progression-free survival (PFS)
Description
compare efficacy between the two treatment arms as assessed by progression-free survival (PFS)
Time Frame
3 - 9 weeks
Title
overall survival (OS)
Description
compare efficacy between the two treatment arms as assessed by overall survival (OS)
Time Frame
3 - 9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 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 Exclusion criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Janni, MD PhD
Phone
+49 731 500 58 501
Email
studienzentrale.ufk@uniklinik-ulm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Krause, M. sc.
Phone
+49 731 500 58 652
Email
sabrina.krause@uniklinik-ulm.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Huober, MD PhD
Organizational Affiliation
Studienzentrale Dpt. Gyn/OB University Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ulm Gynecology/Obstetrics
City
Ulm
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.detect-studien.de
Description
The DETECT study concept

Learn more about this trial

Detect V / CHEVENDO (Chemo vs. Endo)

We'll reach out to this number within 24 hrs