Detect V / CHEVENDO (Chemo vs. Endo)

STATUS

Recruiting
End date

Nov 8, 2024
participants needed

270
sponsor

Prof. W. Janni

Send

Updated on 8 August 2022

See if I qualify

platelet count

paclitaxel

serum pregnancy test

measurable disease

breast cancer

endocrine therapy

metastasis

neutrophil count

hormone therapy

capecitabine

pertuzumab

liver metastasis

HER2

primary tumor

trastuzumab

goserelin

fulvestrant

herceptin

anastrozole

vinorelbine

exemestane

letrozole

eribulin

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.

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.

Details

Condition	Metastatic Breast Cancer
Treatment	Capecitabine, docetaxel, Paclitaxel, Trastuzumab, Letrozole, Nab-paclitaxel, Eribulin, Vinorelbine, Ribociclib, Goserelin, tamoxifen, anastrozole, exemestane, fulvestrant, Pertuzumab, Leuprorelin
Clinical Study Identifier	NCT02344472
Sponsor	Prof. W. Janni
Last Modified on	8 August 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	Signed, written informed consent in study participation
	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
	Adequate organ function within 14 days before randomization, evidenced by the following laboratory results below
	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
	absolute neutrophil count ≥ 1500 cells/µL
	In case of patients of child bearing potential
	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
	Sodium
	Patients must have the following laboratory values within normal limits or corrected
	Potassium
	to within normal limits with supplemets before the first dose of study
	Total calcium
	medication
	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
	Treatment with any other investigational agents during trial
	History of serious cardiac disease, including but not confined to
	history of documented heart failure or systolic dysfunction (LVEF < 50%)
	angina pectoris requiring anti-anginal medication
	clinically significant valvular heart disease
	evidence of transmural infarction on ECG
	Known CNS metastases
	History of hypersensitivity reactions attributed to trastuzumab, pertuzumab
	ribociclib or to other components of drug formulation
	Progression on prior Pertuzumab therapy
	Mandatory need for cytostatic treatment at time of study entry based on clinical
	Dyspnea at rest or other diseases that require continuous oxygen therapy
	Treatment with Pertuzumab within the last 12 months
	judgment and national/international treatment guidelines
	Prior treatment with any mTOR- or CDK4/6-inhibitor
	Patients with known infection with HIV, hepatitis B virus, or hepatitis C virus
	Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition
	Male patients
	Known hypersensitivity to lecithin (soya) or peanuts
	that might interfere with the planned treatment and with the patient's adherence to
	Life expectancy < 6 months
	the protocol
	Participation in another clinical study within the 30 days before registration
	Legal incapacity or limited legal capacity
	Patients with pre-existing grade ≥2 peripheral neuropathy are excluded from
	taxane-based chemotherapy
	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)
	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
	Patients with poorly controlled diabetes or with evidence of clinically significant
	diabetic vascular complications
	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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

Detect V / CHEVENDO (Chemo vs. Endo)