Health TrialsbyHealthPanel

Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction

ConditionsBreast CancerHeart Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPopulation Health Research Institute

About this trial

Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. Heart injury can often be successfully treated using cardiac medications. The objectives of SCHOLAR-2 are to evaluate whether is it safe and effective to continue trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1) in patients with early stage HER-2 positive breast cancer despite mild, minimally symptomatic or asymptomatic systolic left ventricular dysfunction as compared with a guideline-driven approach of withholding or discontinuing trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1).

In SCHOLAR-2, we will compare two thresholds of withholding or discontinuing trastuzumab/pertuzumab/trastuzumab-emtansine: a threshold that is currently advocated for by existing treatment practice guidelines versus a more aggressive threshold that allows trastuzumab/pertuzumab/trastuzumab-emtansine to continue at lower levels of LVEF than currently supported by guideline documents.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage I-III HER-2 positive breast cancer

Receiving adjuvant or neoadjuvant therapy with trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1)

Disqualifiers

Current use of both angiotensin converting enzyme inhibitor (ACEI) /angiotensin receptor blocker (ARB) and beta-blocker

Contra-indication to both ACE-I/ARB and beta-blockers

NYHA class III or IV heart failure

LVEF <40%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trastuzumab

    Drug

    Trastuzumab is a HER-2 targeting monoclonal antibody that improves overall survival and reduces the risk of recurrent disease in early stage HER-2 positive breast cancer.

  • Pertuzumab

    Drug

    Pertuzumab (also called 2C4, trade name Perjeta) is a monoclonal antibody used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2-positive breast cancer; it also used in the same combination as a neoadjuvant in early HER2-positive breast cancer

  • Trastuzumab emtansine

    Drug

    Ado-trastuzumab emtansine is approved to treat: Breast cancer that is HER2 positive and has already been treated with a taxane and trastuzumab.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 3 interventions
Group B: Intervention GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

primary efficacy outcome

the proportion of participants completing trastuzumab, pertuzumab, or trastuzumab-emtansine (T-DM1) as planned at its initiation

Time frame
one year
2

co-primary safety outcomes

1. LVEF at the close-out visit, and 2. The composite of NYHA class III or IV heart failure or cardiovascular death.

Time frame
one year

Secondary outcomes

1

secondary outcome measures the composite of NYHA class III or IV heart failure, breast cancer relapse, or all-cause mortality.

the composite of NYHA class III or IV heart failure, breast cancer relapse, or all-cause mortality.

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Source ClinicalTrials.gov
Apply now