Living Proof (2008) and the Herceptin Trials

This is a Lifetime television film, taken from Robert Bazell's book about the making of Herceptin. It follows Dr Dennis Slamon at UCLA from 1988 to 1996. He is chasing a drug aimed at one protein, called HER2.

Spoilers throughout. Discussing this story means discussing how it ends.

When his drug-company partner stops paying for the work, private donors keep the lab alive. Lilly Tartikoff and Ronald Perelman raise money through Revlon and the Fire and Ice Ball. Animal work leads to three human trials. Nicole, a young mother with stage 4 disease, is the first woman shown getting the drug. But she does not meet the entry rules for the later trials, and she is turned away despite her mother's pleading.

The women in the first trial become a group, coping through humour or through alternative therapies. Barbara Bradfield, a retired art teacher, and Ellie, a designer, are followed through treatment and recovery. Some participants die. The film closes with the drug on course to change breast cancer treatment. Every patient in it except Bradfield is a composite.

The most honest scene in the film is the one where a dying woman is turned away.

Every trial has entry rules. They set out which stage of disease counts, which past treatments rule you out, how well your organs must be working, and which other illnesses matter. The rules exist for two reasons. A trial has to answer one clear question, and a group of patients who are all different answers nothing. The rules also protect people from a drug whose harms are still unknown.

The result is harsh, and the film does not soften it. The sickest and most desperate patients are often the ones the rules shut out. The doctor sitting opposite really cannot bend them. So ask two questions early. What would rule me out? And if it does, is there another route to the drug outside a trial?

The film is also right about two harder things. A drug can change everything for one group of patients and do nothing at all for the rest. And a group of women who go through this together will not all come out the other side.

Eight years become a brisk story driven by one stubborn man. In truth the drug came out of Genentech's science as much as UCLA's, and hundreds of people ran the trials. Fran Visco and the National Breast Cancer Coalition do appear. That is a rare nod to the fact that patient campaigners shaped this drug rather than just receiving it.

Because the patients are composites, their timelines and responses are shaped for effect, and several stay glamorous and lucid deep into metastatic illness.

Side effects are the biggest gap. Trastuzumab carries a boxed warning about damage to the heart muscle. The risk is highest when it is given with a group of chemotherapy drugs called anthracyclines. Because of this, the label tells doctors to check how well the heart is pumping before treatment starts, and again about every three months. None of that checking appears on screen, and it is a real part of taking this drug.

This is the part of the story with a direct use for viewers.

HER2-positive breast cancer causes the same symptoms as any other breast cancer:

• A new lump or thickening in the breast or armpit.
• A change in size or shape.
• Skin dimpling.
• A nipple turning inward.
• Nipple discharge.
• Redness or scaling.
• Pain that does not settle.

Nothing on that list tells you whether a tumor is HER2-positive. No scan shows it. No examination finds it. It is a lab result, taken from tissue removed at biopsy or surgery.

The first test is a stain that shows how much HER2 protein the cells carry. If that result is borderline, a second test counts the gene copies instead. FISH is the best known of those. Two professional bodies, ASCO and the College of American Pathologists, publish rules so that labs get the same answer as each other. That matters, because the answer decides the treatment. The FDA now requires an approved test before this drug can be given at all.

So if you have been diagnosed, the single most useful question is not about the drug. It is: what did my HER2 test show, and was it confirmed?

The film ends in 1996. The FDA approved trastuzumab on 25 September 1998, for metastatic HER2-positive breast cancer.

The bigger chapter came later. Trials gave the drug after surgery to early-stage patients, to cut the risk of the cancer coming back. That is where it changed the most lives, and the film stops years before it. It also stops long before the newer drugs that now work when trastuzumab alone does not.

Screening for breast cancer is a separate matter from all of this. The US Preventive Services Task Force advises a mammogram every two years for women aged 40 to 74. NCI's own evidence review puts the strongest case between 50 and 69 — solid evidence of fewer breast cancer deaths at 60 to 69, fair evidence at 50 to 59 — and describes the benefit for women aged 40 to 49 as uncertain.

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The reason to watch this film is not the science. It is to see breast cancer treatment stop being one thing and become several, sorted by what a lab finds in the tissue. That is why two people with the same diagnosis on paper can be offered quite different drugs. It is also why a breast change needs a proper look, and a biopsy if one is called for, rather than reassurance. Living Proof cannot tell you what to watch for, but screening and possible warning signs can.

This page discusses Living Proof for education. It is not medical advice, and nothing here is a judgement of anyone's real medical care. Spotted an error? Please email [email protected].