Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

Decrescendo : De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Surgical<br/>TrialTypeSurgical
Trial

TwoPhase Two

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Surgical,Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase II study is evaluating the effectiveness of chemotherapy (paclitaxel or docetaxel) combined with targeted therapy (pertuzumab and trastuzumab), followed by surgery, followed by further treatment with targeted therapy or chemotherapy, in people with HER2-positive, ER-negative, Node-negative early breast cancer .
 

This trial is treating patients with breast cancer.

This is a systemic therapy and surgical trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade

Commercial Sponsor

Hoffmann-La Roche

Other Non-Commercial Sponsor

Jules Bordet Institute

Summary

This is an open-label study with multiple phases. Eligible participants will receive neoadjuvant treatment with 12 administrations of weekly intravenous (IV) paclitaxel 80mg/m2 (or IV docetaxel 75mg/m2 every 3 weeks for 4 cycles), combined with subcutaneous injection (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200mg pertuzumab and 600mg trastuzumab, followed by 600mg pertuzumab and 60mg trastuzumab) every 3 weeks for 4 cycles. Following this, all participants will undergo surgery, performed according to local guidelines. After surgery, participants who achieve pathologic complete response (pCR, defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for an additional 14 cycles. Participants with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In participants whose residual invasive disease is classified per Residual Cancer Burden (RCB) score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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