Giving hope to those affected
by secondary breast cancer
Research. Support. Education.
Giving hope to those affected
by secondary breast cancer
30th May 2023 by Alexander Kolliari-Turner Trials
Every month Make 2nds Count updates its registry of all actively recruiting secondary breast cancer clinical trials in the UK. This post highlights some of the new clinical trials added to our registry that are actively recruiting participants within the UK for Spring 2023.
If you are a patient interested in finding out more about clinical trials, check out our Patient Trials Advocate (PTA) Service where our experienced nurses can answer questions, search for trials based on your eligibility and support you in discussing them with your clinician. You can self-refer to the PTA service and there's no waiting list, so why not book a slot with one of our nurses today.
Trial name: FAIM
This phase II clinical trial is recruiting secondary Hormone Receptor positive, Human Epidermal Growth Factor Receptor 2 negative (HR+/HER2-) patients who have had no more than one prior line of chemotherapy and have had previous hormonal therapy. The trial is investigating if circulating tumour DNA (also known as ctDNA) found in a patient's blood can identify cancer progression and predict response to therapy.
In this patient cohort, changes in circulating tumour DNA after 15-days of standard of care of treatment with palbociclib (a CDK4/6 inhibitor) and fulvestrant (a type of hormonal therapy) have been found to strongly predict the length of time a patient remains free of disease progression. Patients who did not have lower levels of circulating tumour DNA had a significantly shorter length of time until disease progression happened, identifying a group who require additional therapy to prevent early progression. This study is researching this group of patients.
The experimental drug ipatasertib (which inhibits a growth pathway known as the PI3K/Akt signalling pathway) will be given to this cohort of patients with lower levels of circulating tumour DNA to see if the length of time until disease progression occurs can be longer.
This UK based trial is sponsored by Pfizer & Hoffmann-La Roche and is currently recruiting in Truro & London. Many other sites throughout the UK will start recruiting in the near future.
Trial name: ASCENT-04
This phase III clinical trial is recruiting secondary triple negative breast cancer (TNBC) patients who have yet to have any treatment and whose tumours express a certain protein marker known as PD-L1 (programmed cell death ligand 1).
One group of patients will be given sacituzumab govitecan-hziy (also known as TRODELVY®) and pembrolizumab (also known as KEYTRUDA) and compared to another group of patients who will be given the current standard of care (TRODELVY® and a type of chemotherapy). The trial primarily aims to see which group of patients has the longest length of time until further disease progression occurs.
This global clinical trial is sponsored by Gilead Sciences and Merck Sharp & Dohme LLC and is currently recruiting in Glasgow & Nottingham.
Trial name: evERA Breast Cancer
This phase III clinical trial is recruiting secondary Estrogen Receptor positive, Human Epidermal Growth Factor Receptor 2 negative (ER+/HER2-) patients, who have had previous treatment with CDK4/6 inhibitors and hormonal therapy.
One group of patients will be given Giredestrant, which is a new type of hormonal therapy drug, alongside Everolimus (also known as Afinitor which is part of standard of care in this cohort of patients). Giredestrant is a type of drug known as a SERD (Selective Estrogen Receptor Degrader) and can inhibit the growth promoting properties of the Estrogen Receptor and lower the levels of Estrogen Receptor in cancer cells.
Another group of patients will be given standard of care hormonal therapy treatment (either Exemestane, Fulvestrant or Tamoxifen depending on physician's choice), alongside Everolimus.
The primary aim of the study is to compare the length of time until disease progression occurs between these two groups, to investigate if patients treated with Giredestrant have better treatment outcomes than the current standard of care.
This global clinical trial is sponsored by Genentech and is currently recruiting in Dorset, Manchester & Nottingham.
Trial name: Study SGN-PDL1V
A Study of SGN-PDL1V in Advanced Solid Tumors
This phase I clinical trial is recruiting secondary triple negative breast cancer (TNBC) patients whose disease is relapsed or refractory (does not respond to current treatments) and has no appropriate standard of care option.
SGN-PDL1V is an investigational drug that targets a protein marker known as PD-L1 (programmed cell death ligand 1). By blocking PD-L1, SGN-PDL1V might better enable the immune system to target cancer cells and SGN-PDL1V has also shown to be toxic to cancer cells in laboratory studies.
As this is a phase I clinical trial, which means SGN-PDL1V is in the beginning phases of being tested in human patients, the primary aim of the trial is to investigate how many patients experience adverse effects and which dosage is safest for patients. The length of time until further disease progression will be measured as a secondary outcome.
This global clinical trial is sponsored by Seagen and started recruiting patients in North America in 2022 as described by an abstract from the annual American Society of Clinical Oncology (ASCO) conference. The trial has now expanded recruitment into into Europe and is currently recruiting in The Royal Marsden Hospital in Surrey.
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