Without a doubt, oncology clinical trials are among the most complex and complicated trials. Two of the primary reasons are:
- Oncology clinical trial design and complexity
- The volume of oncology trial data
To refresh your memory about the five reasons why, read my recent blog, How Different Are Oncology Clinical Trials.
The stakes also tend to be higher for oncology clinical trials. In the case of breast cancer, the numbers are staggering as to how many people are impacted. In the United States, according to the American Cancer Society,
- 1 in 8 women – roughly 13 percent of the female population – will develop breast cancer in their lifetime.
- Except for skin cancers, the most common cancer in American women is breast cancer.
- In 2024, approximately 30 percent of all new female cancer diagnoses will be breast cancer.
- On average, a woman in the US is diagnosed with breast cancer every 2 minutes.
Worldwide, the statistics are equally daunting.
Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death in females worldwide, with an estimated 2.3 million new cancer cases (1 in 4 new cancer cases) and 685,000 cancer deaths (1 in 6 deaths) in 2020.”
Oncology Clinical Trials: I-SPY 2
Enter I-SPY 2, an interventional, randomized adaptive platform trial for newly diagnosed breast cancer patients.
The goal of the I-SPY series of oncology clinical trials is new, better and more personalized breast cancer treatments, faster. I-SPY 2 was one of the first and has become one of the longest-running platform trials ever, growing to 35 sites with nearly 5,000 participants. Following the migration to the OpenClinica platform, I-SPY 2 has successfully evaluated 25 agents, twelve of which have graduated beyond phase 2, three of which received accelerated approval, and one which has earned FDA Breakthrough Therapy Designation.
I-SPY 2 is a hallmark oncology clinical trial for its design and complexity as well as its volume of data. As of March 2025, the I-SPY 2 trial numbers are:
- Participants: 4,906
- Amendments: 37
- Agents Evaluated: 25
- Agents Receiving Accelerated Approval: 3
- Agents Receiving FDA Breakthrough Therapy Designation: 1
- Forms automated: 147,654+
- Data values automated: 20+ million
It is tremendous understatement to write that OpenClinica is proud of our work to help make I-SPY 2 the success it is.
For a deep dive into OpenClinica’s role in the I-SPY 2 oncology clinical trial, download our new case study here!