Synopsis

Explore the pioneering efforts of a biotech company and the many devoted individuals whose independent and collective efforts resulted in the world's first targeted biotechnology therapy for breast cancer. From the earliest scientific discoveries to groundbreaking clinical trials testing the drug in women desperate for hope, this documentary film tells the emotional and compelling story of the researchers, physicians, patients and breast cancer advocates whose personal sacrifice and professional commitment advanced the project from scientific curiosity to a potential lifesaving medicine.

The Herceptin® (trastuzumab) story is told through gripping personal accounts intertwined with historical footage and other archival material, revealing a rarely seen view of drug development. The film chronicles a nearly three-decade journey that begins with the Nobel Prize-winning research that identified a cancer-causing gene for the first time -- a discovery that sparks the imaginations and intellectual curiosity of a group of molecular biologists working at Genentech, a leading California biotechnology company. Working together and in tandem with other leading researchers scattered around the country, they prove that a single gene, HER-2, is the source of an aggressive and deadly form of breast cancer. The discovery sends all of those with a stake in the drug's success down an uncharted and risky path as Genentech attempts to receive FDA approval for Herceptin so that women with HER-2 positive breast cancer have access to the drug.


Indications
Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy
* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

Metastatic indications
Herceptin is indicated:
  • In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
Boxed WARNINGS and Additional Important Safety Information
  • Herceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction. One adjuvant patient, who developed CHF, died of cardiomyopathy.
  • Evaluate cardiac function prior to and during treatment. Discontinue Herceptin for cardiomyopathy.
  • Herceptin can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
  • Exacerbation of chemotherapy-induced neutropenia has also occurred.
  • Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy.
  • Herceptin, when administered to a pregnant woman, can cause fetal harm and post-marketing case reports suggest Herceptin can increase the risk of oligohydramnios.
  • The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
Please see the Herceptin full prescribing information including Boxed WARNINGS and additional important safety information.