KRISTINE
KRISTINE tested whether an antibody-drug conjugate could replace chemotherapy before surgery in HER2-positive breast cancer and found it could not: fewer tumours disappeared and more grew before the operation.
Overview
KRISTINE, trial NCT02131064 sponsored by Roche and Genentech and published in the Lancet Oncology in 2018, randomised 444 patients with stage II or III HER2-positive breast cancer to six cycles of trastuzumab emtansine plus pertuzumab or to docetaxel, carboplatin, trastuzumab and pertuzumab before surgery. Pathological complete response was 44.4 percent with the antibody-drug conjugate against 55.7 percent with chemotherapy, and although the conjugate arm had fewer severe side effects and better quality of life, 15 patients in that arm had locoregional progression before surgery against none with chemotherapy. The three-year follow-up in 2019 showed worse event-free survival with the conjugate driven by those pre-surgical progressions, while invasive disease-free survival after surgery was similar. The trial is the standard warning against replacing chemotherapy with an antibody-drug conjugate on the basis of response rates alone, a lesson revisited when DESTINY-Breast11 kept a chemotherapy phase after trastuzumab deruxtecan.
- 44.4 vs 55.7 out of 100 had no cancer left at surgery with Trastuzumab emtansine + pertuzumab compared with Docetaxel, carboplatin, trastuzumab, pertuzumab; 11.3 fewer per 100.
- On this measure the first group did worse, not better.
- The p-value (0.016) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Stage II to III HER2-positive breast cancer: neoadjuvant trastuzumab emtansine plus pertuzumab vs docetaxel, carboplatin, trastuzumab and pertuzumab. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
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.
444 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Pathological complete response (breast and axilla)primary | Trastuzumab emtansine + pertuzumab | 223 | 44.4% | - | 0.016 | link |
| Docetaxel, carboplatin, trastuzumab, pertuzumab | 221 | 55.7% |
Similar pages
not linked directly; found by shared links- TreatmentTrastuzumab duocarmazine
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- TrialOUTBACK / ANZGOG 0902 / GOG-0274
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- TrialA Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
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- TrialA Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Brea
Shares Pertuzumab, Docetaxel, Trastuzumab, HER2-positive breast cancer.
- TrialA Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Shares Pertuzumab, Docetaxel, Trastuzumab, HER2-positive breast cancer.
- TrialA Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
Shares Trastuzumab emtansine, Pertuzumab, Docetaxel, Trastuzumab.
- TrialA Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
Shares Pertuzumab, Docetaxel, Trastuzumab, HER2-positive breast cancer.