Impact of breast cancer research run by BIG

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True impact, research that saves lives

Some trials conducted by BIG have the potential to change the life of breast cancer patients by:

avoiding unnecessary chemotherapy
cutting relapse rates
providing new treatment combinations
finding safe alternatives

Research saves lives

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There are many areas of research that hold great promise for patients, but have no particular interest for commercial partners. That is why BIG develops and runs studies that hold tremendous potential for patients and promise long-term gains for society, in all regions of the world.

Research is the only way to understand breast cancer, how and why it progresses, and how it can ultimately be stopped.

Since the creation of the not-for-profit in 1999, more than 50 trials have been run under the BIG umbrella, including several landmark trials that have had a real impact on breast cancer treatments and the lives of patients affected by the disease.

Dr. Martine Piccart : "With the incredibly powerful and fascinating technologies under development today, there is a real risk to get « lost in translation ». I believe that we need to put ourselves in our patients’ shoes and focus on issues that matter to them, such as identifying and validating biomarkers that could be linked to an excellent clinical outcome without treatment escalation."

Patients’ needs at the heart of our activities

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Thanks to genetic research on cancer cells over the past decade, we now understand that breast cancer is not one single disease, but many different subtypes. All patients are different and require a unique treatment approach.

Our aim is to find the right treatment for every patient. That’s why BIG’s trials introduce particularly innovative designs, contributing to significant breakthroughs, or paving the way towards more personalised treatment of the disease.

MINDACT trial, 46% could be spared chemotherapy

The first results of the MINDACT trial give hope to many women with early-stage breast cancer: in future, it is possible that up to 46% of patients who would have received chemotherapy in the past can be spared this treatment and its side effects.

The results of this trial can help doctors identify which women need chemotherapy due to the tumour aggressiveness and which women can be spared this additional treatment after surgery.

SOFT & TEXT trials, reducing risk by 35% for young women

The SOFT and TEXT trials, together involving over 5700 patients, indicated that young women with early, hormone-sensitive breast cancer benefit from adding ovarian suppression to the standard treatment with tamoxifen after surgery.

Together, these studies were also the first to demonstrate that taking exemestane, an oral aromatase inhibitor drug, along with blocking ovarian function, reduces cancer recurrence. These practice-changing results provide a new treatment option for young women with hormone-sensitive breast cancer.

Aromatase inhibitors, providing more options to breast cancer patients

Three studies conducted under the BIG umbrella, together recruiting a total of 17.958 patients, contributed to the body of evidence that aromatase inhibitors could be used as a safe alternative to tamoxifen, a drug used to treat oestrogen receptor (ER) positive breast cancer that is associated with dangerous side effects for some women. Not only did these trials prove the effectiveness of the new drugs, but they also answered important additional questions about whether the drugs should be given in combination or in sequence with others, the likelihood of side effects with long-term use, and patients’ overall quality of life.

HERA trial, cutting relapse rates by 50%

Recruiting 5100 women from 480 sites across 39 countries in just over four years – in itself a remarkable achievement – HERA contributed to a new standard of treatment for women with HER2-positive, early breast cancer, a highly aggressive form of the disease. HERA helped accelerate the approval of a drug, trastuzumab, that has cut relapse rates by 50% and is now the standard treatment for this type of breast cancer.

About HERA

The main objective of the HERA trial was to compare the clinical benefits and the effects of giving one and two years of the anti-HER2 therapy trastuzumab (Herceptin®) in addition to standard treatment versus standard treatment alone for patients with HER2-positive early breast cancer.

HER2-positive breast cancer is a particularly aggressive form of the disease that previously meant poor survival rates. In Human Epidermal Growth Factor Receptor (HER) 2-positive breast cancer, increased quantities of a protein known as HER2 that promotes cell growth are present on the surface of the tumour cells. This represents approximately 15-20% of patients with breast cancer.

A total of 5,102 patients were enrolled in the trial between 2001 and 2005 and assigned to one of the following three groups: observation (standard of care); one year of trastuzumab; two years of trastuzumab.

The study’s main results – published in 2005 in the New England Journal of Medicine – indicated that one year of treatment with trastuzumab had a significant and sustained benefit in preventing cancer recurrence and improving overall survival among patients with HER2-positive breast cancer. Two years of the drug was not found to have a significant benefit in comparison to one year of treatment.

The trial conclusions helped accelerate the approval of the drug trastuzumab, which has cut relapse rates by 50% and is now the standard treatment for this type of breast cancer.

The HERA trial enrolled 5,102 women from 480 hospitals across 39 countries in just four years – in itself a remarkable achievement. Involving 27 academic cancer research groups part of the BIG network, it is an example of a successful practice-changing clinical trial since it contributed to a new standard of treatment for women with HER2-positive, early breast cancer, a highly aggressive form of the disease.

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