CompletedPhase IIIInterventional

Response to optimal selection of neo-adjuvant chemotherapy in operable breast cancer

Before having breast cancer surgery, many people receive chemotherapy to shrink their tumour. This is known as neo-adjuvant treatment. However, not every cancer responds to the same drugs in the same way. This trial is testing whether two new laboratory tests can help doctors choose the most effective chemotherapy combination for individual patients. Participants receive standard chemotherapy drugs—such as cyclophosphamide, docetaxel, epirubicin, and 5-fluorouracil—with some also receiving Herceptin if their cancer is HER2-positive. Researchers want to see if tailoring treatment based on these test results leads to better shrinkage of tumours before surgery. If successful, this approach could help future patients receive more personalised, effective care while avoiding treatments that are less likely to work for them.

At a glance

Status

Completed

Phase

Phase III

Sponsor

University of Birmingham

Enrolment target

1,050

Start

01 Jul 2015

Estimated completion

31 May 2023

Breast cancer

What is this study about?

When people are diagnosed with breast cancer, doctors often recommend chemotherapy before surgery. This approach aims to shrink the tumour, making it easier and safer for surgeons to remove. It can also give people a better chance of keeping more of their natural breast tissue. However, breast cancer varies from person to person, meaning a chemotherapy regimen that works very well for one person might not work as well for someone else.

This study, called the ROSCO trial, is exploring whether doctors can use two new laboratory tests to guide treatment decisions. These tests look at specific features of tumour samples to predict how well the cancer is likely to respond to different types of chemotherapy. By studying these markers, researchers hope to take the guesswork out of choosing pre-surgery medicines.

Participants are split into groups to compare different standard chemotherapy combinations, including drugs like cyclophosphamide, docetaxel, and epirubicin. Those whose cancer cells have high levels of a protein called HER2 will also receive a targeted medicine called Herceptin. By comparing the results, doctors hope to learn if matching treatments to a person's specific test results helps clear more cancer cells before surgery.

Ultimately, this research matters because more tailored treatment could improve long-term outcomes and reduce unnecessary side effects. Rather than taking a one-size-fits-all approach, doctors want to ensure every person gets the exact treatment most likely to work best for them.

Key takeaways

The trial tests if new lab tests can tailor chemotherapy before breast cancer surgery.
It is open to adults with invasive breast cancer that measures at least 20 mm or involves nearby lymph nodes.
Participants receive standard chemotherapy drugs, with some also receiving Herceptin.
Your heart, kidneys, liver, and blood counts will be thoroughly checked for safety.
Participation is entirely voluntary and will not affect your standard NHS rights.

Who may be eligible?

This trial is open to adults aged 18 and older who have been diagnosed with invasive breast cancer that can be operated on after initial treatment. It includes people with a single tumour measuring at least 20 millimetres across, as well as those with several smaller tumours that add up to that size. People whose cancer has spread to nearby skin, chest wall muscles, or lymph nodes in the armpit or collarbone may also take part.

Both men and women can join, whether the cancer is in one breast or both. People with any HER2 status are welcome. However, to ensure it is safe to take part, doctors must check that participants are generally well enough to manage chemotherapy. This includes checking blood counts and testing how well the liver, kidneys, and heart are working, especially for those receiving Herceptin.

You cannot take part if you have serious underlying heart problems or if your organ function tests show that chemotherapy would be unsafe for you. Your hospital care team will run these standard health checks to confirm whether joining is suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with invasive breast cancer.
My tumour is at least 20 mm in size or has spread to nearby skin, chest wall, or lymph nodes.
My doctor recommends chemotherapy before I have surgery.
I have satisfactory heart, kidney, liver, and blood test results.

Answer every question to see your result.

What does participation involve?

Taking part involves having your usual pre-surgery care guided by the trial protocol. Before treatment starts, your team will collect tumour samples from your initial biopsy and perform standard health checks, such as blood tests, physical exams, and a heart scan. You will then be randomly assigned by a computer to receive one of the standard chemotherapy combinations. Chemotherapy is given through a drip into a vein at regular hospital visits, usually every two to three weeks over several months. If your cancer is HER2-positive, you will also receive Herceptin. Throughout treatment, the team will closely monitor your general health, blood counts, and tumour size. Once your chemotherapy course is complete, you will have your planned breast surgery. Doctors will then check the removed tissue to see how much cancer remains, and you will have routine follow-up visits to track your recovery over time.

Potential risks and benefits

Taking part may mean your chemotherapy is better suited to your cancer, potentially shrinking the tumour more effectively before surgery. The information gathered will also help improve future breast cancer treatments. However, chemotherapy drugs cause common side effects, including tiredness, nausea, hair loss, an increased risk of infections, and occasional heart strain. There is also no guarantee that the trial approach will work better than standard care. Joining is completely voluntary, and you can choose to leave the study at any time without your regular NHS care or relationship with your medical team being affected.

Locations (1)

Cancer Research UK
Approximate
Birmingham, England

Common questions

What does neo-adjuvant treatment mean?

It simply means receiving treatment, such as chemotherapy, before having surgery to shrink the tumour and make it easier to remove.

Will I receive real chemotherapy drugs during the study?

Yes. Every participant receives active, approved chemotherapy medicines; no one is given a placebo or dummy treatment.

Do I have to pay to take part?

No. The trial is run through hospital cancer services, and all study treatments and tests are provided free of charge.

Can I leave the trial if I find the side effects too difficult?

Yes. You are free to stop participating at any point, and your doctors will discuss standard treatment alternatives with you.

How is my treatment combination chosen?

A secure computer system randomly allocates you to a treatment group based on the study design and your specific cancer features.

How to find out more

ROSCO Trial Coordinator

rosco@trials.bham.ac.uk +44 (0)121 414 3604 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.