CheckMate 7FL - Clinical trial • Breast Cancer Foundation NZ

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CheckMate 7FL

Early Breast Cancer clinical trials for ER+

Recruiting
Updated: July 6, 2020

A study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk ER+, HER2- early stage breast cancer.

A study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk ER+, HER2- early stage breast cancer.

Who is it for?

You may be eligible for this study if you meet the below criteria:

  • Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥ 2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Nodal status must be cytologically confirmed. Note: Inflammatory breast cancer is allowed.
  • ER+ breast cancer and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample and tested by the central laboratory, as defined in the relevant American Society of Clinical Oncology [ASCO] - College of American Pathologists[CAP] Guidelines.
  • Must agree to provide primary breast tumor tissue at baseline and at surgery.
  • Must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy.
  • Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial.
  • Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.

Study details

Nivolumab combined with neoadjuvant chemotherapy and adjuvant endocrine therapy: Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice

Placebo combined with neoadjuvant chemotherapy and adjuvant endocrine therapy: Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice

For full trial information

Australia

Mater Hospital, Sydney
Port Macquarie Base Hospital, Port Macquarie
Calvary Central Districts Hospital, Elizabeth Vale
Monash Medical Centre Clayton, Clayton
Ballarat Base Hospital, Ballarat

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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