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I-SPY 1 followed women having chemotherapy before breast surgery with repeated MRI scans and biopsies, and showed that a tumour vanishing completely (a pathological complete response) predicted long-term survival, especially in the aggressive subtypes.
I-SPY 1 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) ran from 2002 to 2006 across nine United States centres, led by Laura Esserman at UCSF with the Cancer and Leukemia Group B and the American College of Radiology Imaging Network. Women with tumours of three centimetres or more received standard anthracycline and taxane chemotherapy before surgery while the study collected MRI scans, core biopsies and blood at set points.
Its findings set the rules for everything that followed: a pathological complete response, no invasive cancer left in the breast and nodes at surgery, predicted recurrence-free survival, and the prediction was strongest in triple-negative and HER2-positive disease and in tumours the MammaPrint test called high risk. Change in tumour volume on MRI after the first cycles also predicted response, which made early imaging a way to tell quickly whether a drug was working.
The trial built the biomarker-defined subtypes, the imaging protocol and the multi-centre infrastructure that I-SPY 2 turned into a permanent platform.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Numbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Recurrence-free survival, pathological complete response versus no pCR (172 patients treated without trastuzumab)primary | Pathological complete response | - | - | 0.29 (0.07 to 0.82) | - | link |
| No pathological complete response | - | - | ||||
| Pathological complete response by receptor subset (190 patients treated without trastuzumab) | HR-negative / HER2-positive | - | 45% | - | - | link |
| HR-positive / HER2-negative | - | 9% |
Shares Laura J. Esserman, Master protocol (platform, basket and umbrella trials), UCSF Helen Diller Family Comprehensive Cancer Center, Pathologic complete response (pCR).
Shares Gene-expression prognostic assays, Laura J. Esserman, Master protocol (platform, basket and umbrella trials), UCSF Helen Diller Family Comprehensive Cancer Center.
Shares Laura J. Esserman, UCSF Helen Diller Family Comprehensive Cancer Center, Pathologic complete response (pCR), Breast cancer (all types).
Shares Laura J. Esserman, UCSF Helen Diller Family Comprehensive Cancer Center, Breast cancer (all types).
Shares Laura J. Esserman, UCSF Helen Diller Family Comprehensive Cancer Center, Triple-negative breast cancer (TNBC).
Shares Alliance for Clinical Trials in Oncology, Pathologic complete response (pCR), HER2-positive breast cancer, Breast cancer (all types).
Shares Laura J. Esserman, UCSF Helen Diller Family Comprehensive Cancer Center, Breast cancer (all types).
Shares Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, HER2-positive breast cancer, Breast cancer (all types).