What changed: HER2-positive breast cancer
Every dated change on the records linked to HER2-positive breast cancer, newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
September 2026 · 1
June 2026 · 1
Q2 2026 · 1
2026 · 2
February 2025 · 1
2025 · 7
- 2025Trial resultBWEL (Breast Cancer Weight Loss, Alliance A011401)BWEL (Breast Cancer Weight Loss, Alliance A011401) reported
Weight loss achieved; primary iDFS endpoint not met at first analysis (presented 2025; publication pending, verify).
- 2025Trial resultDESTINY-Breast05DESTINY-Breast05 reported
3-year iDFS 92.
- 2025Trial resultDESTINY-Breast09DESTINY-Breast09 reported
PFS HR 0.
- 2025Trial resultDESTINY-Breast11DESTINY-Breast11 reported
pCR 67.
- 2025Trial resultHER2CLIMB-05HER2CLIMB-05 reported
PFS 24.
- 2025Trial resultHORIZON-Breast01HORIZON-Breast01 reported
PFS 30.
- 2025MilestoneDESTINY-Breast09DESTINY-Breast09 first-line approval; DESTINY-Breast05 and HER2CLIMB-05 positive; trastuzumab rezetecan approved (China, NSCLC)
A milestone in how this cancer is treated.
2024 · 5
- 2024Trial resultACE-Breast-02ACE-Breast-02 reported
PFS 11.
- 2024Trial resultDESTINY-Breast12DESTINY-Breast12 reported
CNS ORR 71.
- 2024Trial resultI-SPY 2.2I-SPY 2.2 reported
Ongoing; the first block results and de-escalation rates were reported from 2024.
- 2024Trial resultPHERGainPHERGain reported
3-year iDFS 95.
- 2024MilestonePHERGainPHERGain chemotherapy omission; DESTINY-Breast12 brain metastases; zanidatamab approved (BTC)
A milestone in how this cancer is treated.
2023 · 2
2021 · 3
June 2020 · 1
2020 · 6
- 2020ApprovalInetetamabInetetamab approved in CN
HER2-positive metastatic breast cancer after chemotherapy, with vinorelbine
- 2020ApprovalMargetuximabMargetuximab approved in US
HER2+ metastatic breast cancer after ≥2 anti-HER2 regimens, with chemotherapy
- 2020ApprovalNeratinibNeratinib approved in US
HER2+ metastatic breast cancer with capecitabine after ≥2 anti-HER2 regimens
- 2020ApprovalPertuzumabPertuzumab approved in US
Phesgo subcutaneous fixed-dose combination with trastuzumab
- 2020Trial resultFAST-ForwardFAST-Forward reported
5-year ipsilateral breast tumour relapse 1.
- 2020MilestoneTucatinibTucatinib, margetuximab, Phesgo approved
A milestone in how this cancer is treated.
May 2019 · 1
2019 · 5
- 2019ApprovalTrastuzumab emtansineTrastuzumab emtansine approved in US
Adjuvant HER2+ breast cancer with residual disease after neoadjuvant therapy
- 2019Trial resultHER2CLIMBHER2CLIMB reported
OS 21.
- 2019Trial resultNSABP B-39/RTOG 0413NSABP B-39/RTOG 0413 reported
10-year ipsilateral breast tumour recurrence 4.
- 2019Trial resultPERSEPHONEPERSEPHONE reported
4-year DFS 89.
- 2019MilestoneTrastuzumab deruxtecanT-DXd approved; HER2CLIMB proves CNS benefit
A milestone in how this cancer is treated.
2018 · 3
December 2017 · 1
2017 · 5
- 2017ApprovalNeratinibNeratinib approved in US
Extended adjuvant HER2+ early breast cancer after trastuzumab
- 2017ApprovalPertuzumabPertuzumab approved in US
Adjuvant HER2+ early breast cancer at high risk of recurrence
- 2017Trial resultAPHINITYAPHINITY reported
8-year iDFS HR 0.
- 2017Trial resultIMPORT LOWIMPORT LOW reported
5-year local relapse 0.
- 2017MilestoneTrastuzumab biosimilarsFirst trastuzumab biosimilar; neratinib; APHINITY
A milestone in how this cancer is treated.
2016 · 1
2015 · 4
- 2015Trial resultAPT (adjuvant paclitaxel-trastuzumab)APT (adjuvant paclitaxel-trastuzumab) reported
7-year DFS 93%; 10-year RFI 96.
- 2015Trial resultEORTC 22922/10925EORTC 22922/10925 reported
10-year overall survival 82.
- 2015Trial resultNCIC MA.20NCIC MA.20 reported
10-year disease-free survival 82.
- 2015MilestoneAPT (adjuvant paclitaxel-trastuzumab)APT: de-escalation for small tumours
A milestone in how this cancer is treated.
September 2013 · 1
February 2013 · 1
2013 · 4
- 2013ApprovalPertuzumabPertuzumab approved in US
Neoadjuvant HER2+ early breast cancer (accelerated; first pCR-based approval)
- 2013ApprovalTrastuzumab emtansineTrastuzumab emtansine approved in US
HER2+ metastatic breast cancer after trastuzumab and taxane
- 2013MilestoneTrastuzumab emtansineFirst solid-tumour ADC: T-DM1
A milestone in how this cancer is treated.
- 2013MilestoneTrastuzumab emtansineT-DM1: first solid-tumour ADC; pertuzumab first pCR-based approval
A milestone in how this cancer is treated.
June 2012 · 1
2012 · 3
- 2012ApprovalPertuzumabPertuzumab approved in US
First-line HER2+ metastatic breast cancer with trastuzumab and docetaxel
- 2012Trial resultI-SPY 1 (CALGB 150007/150012, ACRIN 6657)I-SPY 1 (CALGB 150007/150012, ACRIN 6657) reported
Pathological complete response and early MRI volume change predicted recurrence-free survival, most strongly in triple-negative, HER2-positive and MammaPrint high-risk tumours.
- 2012MilestonePertuzumabPertuzumab and dual blockade (CLEOPATRA)
A milestone in how this cancer is treated.
2011 · 1
2010 · 1
2008 · 1
2007 · 2
2005 · 2
- 2005Trial resultHERA, NSABP B-31 & NCCTG N9831 (adjuvant trastuzumab)HERA, NSABP B-31 & NCCTG N9831 (adjuvant trastuzumab) reported
B-31/N9831 10-year OS 84% vs 75.
- 2005MilestoneHERA, NSABP B-31 & NCCTG N9831 (adjuvant trastuzumab)Adjuvant trastuzumab halves recurrence (HERA, B-31/N9831)
A milestone in how this cancer is treated.
1998 · 2
1997 · 1
1987 · 2
- 1987MilestoneHER2-positive breast cancerSlamon shows HER2 amplification marks aggressive disease, and a drug target
A milestone in how this cancer is treated.
- 1987MilestoneHER2Slamon shows HER2 amplification marks aggressive disease, and a drug target
Science paper identifying HER2/neu amplification in 25-30% of breast cancers.