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Breast Cancer

Designed with learners in mind, this section breaks down the most important breast cancer trials into simple, digestible summaries. Whether you’re reviewing for exams or building clinical confidence, start here to master the evidence that shapes modern oncology.

🧪 ATAC Trial
  1. Trial Name / Acronym
    ATAC (Arimidex, Tamoxifen, Alone or in Combination)
  2. Publication Details
    • Title: “Anastrozole Alone or in Combination with Tamoxifen vs Tamoxifen Alone”
    • Journal: Lancet
    • Year: 2002
    • DOI: 10.1016/S0140-6736(02)07739-6
  3. Study Design
    • Phase III, double-blind, randomized controlled trial
  4. Patient Population
    • Postmenopausal women with localized, early-stage ER+ breast cancer
  5. Number of Patients
    • Total: 9,366
  • Anastrozole: ~3,125
  • Tamoxifen: ~3,116
  • Combination: ~3,125 (later closed)
  1. Interventions Compared
    • Anastrozole vs tamoxifen vs combination
  2. Primary and Secondary Endpoints
    • Primary: Disease-free survival
    • Secondary: OS, safety
  3. Key Findings
    • Anastrozole improved DFS vs tamoxifen; fewer thromboembolic/endometrial events
  4. Impact on Clinical Practice
    • Shifted standard adjuvant therapy toward aromatase inhibitors in postmenopausal women
  5. Trial Sponsor / Group
    • Sponsor: AstraZeneca
  1. Trial Name / Acronym
    NSABP B‑14
  2. Publication Details
    • Title: “Tamoxifen for Patients with Node-Negative, Estrogen Receptor–Positive Breast Cancer”
    • Journal: JCO
    • Year: 1990
    • DOI: 10.1200/JCO.1990.8.2.203
  3. Study Design
    • Phase III, randomized, double-blind, placebo-controlled
  4. Patient Population
    • Women with node-negative, ER-positive invasive breast cancer
  5. Number of Patients
    • Total: 2,891
  • Tamoxifen: ~1,452
  • Placebo: ~1,439
  1. Interventions Compared
    • Tamoxifen 20 mg daily × 5 years vs placebo
  2. Primary and Secondary Endpoints
    • Primary: Disease-free survival
    • Secondary: Overall survival, toxicity
  3. Key Findings
    • Significant improvement in DFS and OS with tamoxifen
  4. Impact on Clinical Practice
    • Established tamoxifen as standard adjuvant endocrine therapy in ER+ early breast cancer
  5. Trial Sponsor / Group
    • Sponsor: NSABP
  1. Trial Name / Acronym
    TEXT & SOFT
  2. Publication Details
    • Title: “Adjuvant Ovarian Suppression in Premenopausal Breast Cancer”
    • Journal: NEJM
    • Year: 2014
    • DOI: 10.1056/NEJMoa1412389
  3. Study Design
    • Phase III, randomized controlled, international, companion studies
  4. Patient Population
    • Premenopausal women with HR+ early breast cancer
  5. Number of Patients
    • Total: 4,690
  • Tamoxifen alone: ~1,526
  • Tamoxifen + OFS: ~1,524
  • Exemestane + OFS: ~1,640
  1. Interventions Compared
    • Tamoxifen alone vs tamoxifen + OFS vs exemestane + OFS
  2. Primary and Secondary Endpoints
    • Primary: Disease-free survival
    • Secondary: OS, distant recurrence
  3. Key Findings
    • Exemestane + OFS improved DFS vs tamoxifen alone; greatest benefit in women <35 or those receiving chemo
  4. Impact on Clinical Practice
    • Supported adding OFS (esp with AI) in high-risk premenopausal women
  5. Trial Sponsor / Group
    • International Breast Cancer Study Group (IBCSG) / Breast International Group
  1. Trial Name / Acronym
    TAILORx
  2. Publication Details
    • Title: “Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer”
    • Journal: NEJM
    • Year: 2018
    • DOI: 10.1056/NEJMoa1804710
  3. Study Design
    • Phase III, prospective, randomized, multicenter trial
  4. Patient Population
    • Women with HR+, HER2–, node-negative early-stage breast cancer
  5. Number of Patients
    • Total: 10,273
  • Low RS (0–10): ~1,629
  • Intermediate RS (11–25): ~6,711
  • High RS (26–100): ~1,000
  1. Interventions Compared
    • Endocrine therapy alone vs endocrine therapy + chemotherapy in intermediate RS group
  2. Primary and Secondary Endpoints
    • Primary: Invasive disease-free survival (IDFS)
    • Secondary: OS, distant recurrence
  3. Key Findings
    • No chemo benefit in most women with RS 11–25; younger women (<50) with RS 16–25 had modest benefit
  4. Impact on Clinical Practice
    • Enabled many patients to safely skip chemotherapy using genomic risk stratification
  5. Trial Sponsor / Group
    • Sponsor: ECOG-ACRIN / NCI
  1. Trial Name / Acronym
    RxPONDER
  2. Publication Details
    • Title: “Adjuvant Chemotherapy Guided by 21-Gene Expression Score in Node-Positive Breast Cancer”
    • Journal: NEJM
    • Year: 2021
    • DOI: 10.1056/NEJMoa2108873
  3. Study Design
    • Phase III, randomized controlled trial
  4. Patient Population
    • Women with HR+, HER2– breast cancer, 1–3 positive lymph nodes, RS ≤25
  5. Number of Patients
    • Total: 5,015
  • Endocrine therapy alone: ~2,507
  • Endocrine therapy + chemo: ~2,508
  1. Interventions Compared
    • Endocrine therapy alone vs endocrine therapy + chemotherapy
  2. Primary and Secondary Endpoints
    • Primary: Invasive disease-free survival
    • Secondary: OS, distant recurrence
  3. Key Findings
    • Postmenopausal: no chemo benefit; premenopausal: chemo improved outcomes even at low RS
  4. Impact on Clinical Practice
    • Refined chemo decisions by incorporating menopausal status alongside genomic risk
  5. Trial Sponsor / Group
    • Sponsor: SWOG / NCI
  1. Trial Name / Acronym
    NSABP B-31
  2. Publication Details
    • Title: “Trastuzumab after Adjuvant Chemotherapy in HER2-Positive Breast Cancer”
    • Journal: NEJM
    • Year: 2005 (updated analyses later)
    • DOI: 10.1056/NEJMoa053203
  3. Study Design
    • Phase III, randomized, multicenter
  4. Patient Population
    • Women with node-positive, HER2+ operable breast cancer
  5. Number of Patients
    • Total: ~2,000
  • Chemo alone: ~1,000
  • Chemo + trastuzumab: ~1,000
  1. Interventions Compared
    • Doxorubicin + cyclophosphamide → paclitaxel ± trastuzumab
  2. Primary and Secondary Endpoints
    • Primary: Disease-free survival (DFS)
    • Secondary: Overall survival (OS), cardiac toxicity
  3. Key Findings
    • Adding trastuzumab dramatically reduced recurrence and improved OS
  4. Impact on Clinical Practice
    • Established trastuzumab with chemo as standard adjuvant therapy in HER2+ early breast cancer

Trial Sponsor / Group
• NSABP (National Surgical Adjuvant Breast and Bowel Project)

  1. Trial Name / Acronym
    NCCTG N9831
  2. Publication Details
    • Title: “Trastuzumab plus Adjuvant Chemotherapy for HER2-Positive Breast Cancer”
    • Journal: NEJM (combined report with NSABP B-31, 2005; separate updates published later)
    • DOI: 10.1056/NEJMoa053238
  3. Study Design
    • Phase III, randomized, multicenter
  4. Patient Population
    • Women with HER2+ operable breast cancer (mostly node-positive)
  5. Number of Patients
    • Total: ~2,800 (with several treatment arms)
  6. Interventions Compared
    • Doxorubicin + cyclophosphamide → paclitaxel ± trastuzumab (concurrent vs sequential)
  7. Primary and Secondary Endpoints
    • Primary: DFS
    • Secondary: OS, cardiac safety
  8. Key Findings
    • Concurrent trastuzumab with paclitaxel improved DFS and OS; sequential less effective
  9. Impact on Clinical Practice
    • Supported concurrent trastuzumab as standard approach after AC → taxane in HER2+ patients
  10. Trial Sponsor / Group
    • North Central Cancer Treatment Group (NCCTG), now part of Alliance
  1. Trial Name / Acronym
    APHINITY
  2. Publication Details
    • Title: “Pertuzumab in HER2-Positive Early Breast Cancer”
    • Journal: NEJM
    • Year: 2017
    • DOI: 10.1056/NEJMoa1703643
  3. Study Design
    • Phase III, randomized, double-blind, placebo-controlled
  4. Patient Population
    • Patients with operable HER2+ early breast cancer who completed surgery
  5. Number of Patients
    • Total: 4,805
  • Pertuzumab + trastuzumab + chemo: 2,400
  • Placebo + trastuzumab + chemo: 2,405
  1. Interventions Compared
    • Standard adjuvant chemo + trastuzumab ± pertuzumab (for 1 year)
  2. Primary and Secondary Endpoints
    • Primary: Invasive disease-free survival (IDFS)
    • Secondary: OS, cardiac safety
  3. Key Findings
    • Small but significant improvement in IDFS (especially in node-positive patients)
  4. Impact on Clinical Practice
    • Added pertuzumab to adjuvant regimen for higher-risk HER2+ early breast cancer

Trial Sponsor / Group
• Sponsor: F. Hoffmann–La Roche / Genentech

  1. Trial Name / Acronym
    KATHERINE
  2. Publication Details
    • Title: “Trastuzumab Emtansine vs Trastuzumab in HER2+ Breast Cancer with Residual Invasive Disease”
    • Journal: NEJM
    • Year: 2019
    • DOI: 10.1056/NEJMoa1814017
  3. Study Design
    • Phase III, randomized controlled trial
  4. Patient Population
    • Patients with HER2+ breast cancer and residual invasive disease post-neoadjuvant therapy
  5. Number of Patients
    • Total: 1,486
  • T-DM1: 743
  • Trastuzumab: 743
  1. Interventions Compared
    • Adjuvant T-DM1 vs trastuzumab
  2. Primary and Secondary Endpoints
    • Primary: Invasive disease-free survival
    • Secondary: Distant recurrence, OS
  3. Key Findings
    • T-DM1 reduced invasive recurrence risk by ~50% compared to trastuzumab
  4. Impact on Clinical Practice
    • T-DM1 became standard for residual disease after neoadjuvant HER2-targeted therapy
  5. Trial Sponsor / Group
    • Sponsor: Genentech / Roche
  1. Trial Name / Acronym
    KRISTINE
  2. Publication Details
    • Title: “Neoadjuvant Trastuzumab Emtansine and Pertuzumab vs Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab in HER2-Positive Breast Cancer”
    • Journal: Lancet Oncology
    • Year: 2018
    • DOI: 10.1016/S1470-2045(18)30110-0
  3. Study Design
    • Phase II, randomized, open-label, multicenter trial
  4. Patient Population
    • Women with stage II–III, HER2+ operable breast cancer
  5. Number of Patients
    • Total: 444
  • T-DM1 + pertuzumab: 223
  • Docetaxel + carboplatin + trastuzumab + pertuzumab (TCHP): 221
  1. Interventions Compared
    • Neoadjuvant T-DM1 + pertuzumab vs standard TCHP chemo regimen
  2. Primary and Secondary Endpoints
    • Primary: Pathologic complete response (pCR) in breast and nodes
    • Secondary: Event-free survival, safety, surgical outcomes
  3. Key Findings
    • Lower pCR with T-DM1 + pertuzumab (44.4%) vs TCHP (55.7%)
    • Fewer grade ≥3 toxicities in T-DM1 arm
  4. Impact on Clinical Practice
    • Showed that de-escalated, less toxic regimens like T-DM1 + pertuzumab are feasible but achieve lower pCR than standard chemo
  5. Trial Sponsor / Group
    • Sponsor: Genentech / Roche
  1. Trial Name / Acronym
    KEYNOTE‑522
  2. Publication Details
    • Title: “Pembrolizumab with Chemotherapy in Early Triple-Negative Breast Cancer”
    • Journal: NEJM
    • Year: 2020
    • DOI: 10.1056/NEJMoa1910549
  3. Study Design
    • Phase III, randomized, placebo-controlled trial
  4. Patient Population
    • Patients with newly diagnosed stage II/III triple-negative breast cancer
  5. Number of Patients
    • Total: 1,174
  • Pembrolizumab arm: ~784
  • Placebo arm: ~390
  1. Interventions Compared
    • Chemo + pembrolizumab → pembrolizumab maintenance vs chemo + placebo → placebo
  2. Primary and Secondary Endpoints
    • Primary: pCR, event-free survival
    • Secondary: OS, safety
  3. Key Findings
    • pCR rate improved (64.8% vs 51.2%); trend toward improved EFS
  4. Impact on Clinical Practice
    • FDA approved pembrolizumab + chemo in high-risk early TNBC
  5. Trial Sponsor / Group
    • Sponsor: Merck
  1. Trial Name / Acronym
    IMpassion130
  2. Publication Details
    • Title: “Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer”
    • Journal: NEJM
    • Year: 2018
    • DOI: 10.1056/NEJMoa1809615
  3. Study Design
    • Phase III, randomized, double-blind, placebo-controlled
  4. Patient Population
    • Patients with previously untreated metastatic or unresectable locally advanced triple-negative breast cancer
  5. Number of Patients
    • Total: 902
  • Nab-paclitaxel + atezolizumab: 451
  • Nab-paclitaxel + placebo: 451
  1. Interventions Compared
    • Nab-paclitaxel + atezolizumab vs nab-paclitaxel + placebo
  2. Primary and Secondary Endpoints
    • Primary: PFS and OS (in intention-to-treat and PD-L1+ subgroups)
    • Secondary: Safety, ORR
  3. Key Findings
    • PD-L1+ subgroup had OS improvement (25 vs 15.5 months); no benefit in PD-L1– tumors
  4. Impact on Clinical Practice
    • First immune checkpoint inhibitor approved in metastatic TNBC (later withdrawn in US, but historically transformative)
  5. Trial Sponsor / Group
    • Sponsor: Genentech / Roche
  1. Trial Name / Acronym
    CREATE-X
  2. Publication Details
    • Title: “Adjuvant Capecitabine in Breast Cancer After Neoadjuvant Chemotherapy”
    • Journal: NEJM
    • Year: 2017
    • DOI: 10.1056/NEJMoa1612645
  3. Study Design
    • Phase III, open-label, randomized controlled trial
  4. Patient Population
    • Patients with HER2– invasive breast cancer and residual disease after neoadjuvant chemotherapy
  5. Number of Patients
    • Total: 910
  • Capecitabine: 455
  • Standard care: 455
  1. Interventions Compared
    • Standard care ± 6–8 cycles of adjuvant capecitabine
  2. Primary and Secondary Endpoints
    • Primary: Disease-free survival (DFS)
    • Secondary: OS, safety
  3. Key Findings
    • Capecitabine improved DFS and OS, especially in triple-negative subgroup
  4. Impact on Clinical Practice
    • Capecitabine became standard for residual TNBC after neoadjuvant chemo
  5. Trial Sponsor / Group
    • Sponsor: Japan Breast Cancer Research Group
  1. Trial Name / Acronym
    OlympiA
  2. Publication Details
    • Title: “Adjuvant Olaparib for Germline BRCA-Mutated Breast Cancer”
    • Journal: NEJM
    • Year: 2021
    • DOI: 10.1056/NEJMoa2105215
  3. Study Design
    • Phase III, double-blind, placebo-controlled
  4. Patient Population
    • Patients with HER2–, high-risk early breast cancer and germline BRCA1/2 mutation
  5. Number of Patients
    • Total: 1,836
  • Olaparib: 921
  • Placebo: 915
  1. Interventions Compared
    • Olaparib 1 year vs placebo after standard local and systemic therapy
  2. Primary and Secondary Endpoints
    • Primary: Invasive disease-free survival
    • Secondary: OS, safety
  3. Key Findings
    • Improved DFS and OS with olaparib
  4. Impact on Clinical Practice
    • FDA approval of olaparib in adjuvant setting for high-risk germline BRCA+ patients
  5. Trial Sponsor / Group
    • Sponsor: AstraZeneca

(Grouped together: all landmark CDK4/6 inhibitor trials)

  1. Publication Details
    • Key papers in NEJM, Lancet Oncology, JCO (2015–2021)
  2. Study Design
    • Phase III, randomized, placebo-controlled trials
  3. Patient Population
    • HR+, HER2– advanced/metastatic breast cancer
  4. Number of Patients
    • MONALEESA-2: 668
    • PALOMA-3: 521
    • MONARCH-2: 669
  5. Interventions Compared
    • CDK4/6 inhibitor (ribociclib, palbociclib, abemaciclib) + endocrine therapy vs endocrine therapy alone
  6. Primary and Secondary Endpoints
    • Primary: Progression-free survival (PFS)
    • Secondary: OS, ORR, safety
  7. Key Findings
    • Significant PFS improvement; MONALEESA-2 & MONARCH-2 showed OS benefit
  8. Impact on Clinical Practice
    • CDK4/6 inhibitors became standard first-line therapy in HR+, HER2– metastatic breast cancer
  9. Trial Sponsor / Group
    • Sponsors: Novartis (ribociclib), Pfizer (palbociclib), Lilly (abemaciclib)
  1. Trial Name / Acronym
    SOLAR-1
  2. Publication Details
    • Title: “Alpelisib + Fulvestrant in PIK3CA-Mutated, HR+, HER2– Advanced Breast Cancer”
    • Journal: NEJM
    • Year: 2019
    • DOI: 10.1056/NEJMoa1813904
  3. Study Design
    • Phase III, randomized, double-blind, placebo-controlled
  4. Patient Population
    • HR+, HER2– advanced breast cancer, PIK3CA-mutant and wild-type cohorts
  5. Number of Patients
    • Total: 572
  • PIK3CA-mutant cohort: ~341
  1. Interventions Compared
    • Alpelisib + fulvestrant vs placebo + fulvestrant
  2. Primary and Secondary Endpoints
    • Primary: PFS in PIK3CA-mutant group
    • Secondary: OS, safety
  3. Key Findings
    • PFS doubled in PIK3CA-mutant: 11.0 vs 5.7 months
  4. Impact on Clinical Practice
    • First PI3K inhibitor approved for HR+, HER2– breast cancer with PIK3CA mutation
  5. Trial Sponsor / Group
    • Sponsor: Novartis
  1. Trial Name / Acronym
    EMERALD
  2. Publication Details
    • Title: “Elacestrant vs Standard Endocrine Therapy in ESR1-Mutated Breast Cancer”
    • Journal: JCO
    • Year: 2022
    • DOI: 10.1200/JCO.21.01392
  3. Study Design
    • Phase III, randomized, open-label
  4. Patient Population
    • Postmenopausal women with ER+, HER2– advanced breast cancer, progressed on prior endocrine therapy
  5. Number of Patients
    • Total: 477
  • Elacestrant: 239
  • Standard of care: 238
  1. Interventions Compared
    • Elacestrant vs investigator’s choice of fulvestrant or AI
  2. Primary and Secondary Endpoints
    • Primary: PFS in full population and ESR1-mutant subgroup
    • Secondary: OS, safety
  3. Key Findings
    • Improved PFS, especially in ESR1-mutant patients
  4. Impact on Clinical Practice
    • FDA approval of elacestrant: first oral SERD targeting ESR1 mutations
  5. Trial Sponsor / Group
    • Sponsor: Radius Health
  1. Trial Name / Acronym
    MINDACT
  2. Publication Details
    • Title: “70-Gene Signature as an Aid to Chemotherapy Decisions in Breast Cancer”
    • Journal: NEJM
    • Year: 2016
    • DOI: 10.1056/NEJMoa1602253
  3. Study Design
    • Prospective, randomized, phase III trial
  4. Patient Population
    • Early-stage breast cancer; clinical high or low risk and genomic high or low risk by MammaPrint
  5. Number of Patients
    • Total: 6,693
  6. Interventions Compared
    • Chemo vs no chemo based on combined clinical/genomic risk
  7. Primary and Secondary Endpoints
    • Primary: Distant metastasis-free survival
    • Secondary: OS, DFS
  8. Key Findings
    • High clinical / low genomic risk: excellent outcomes without chemo
  9. Impact on Clinical Practice
    • Supported genomic testing to de-escalate chemo in selected patients
  10. Trial Sponsor / Group
    • Sponsor: EORTC / Breast International Group
  1. Trial Name / Acronym
    ACOSOG Z0011
  2. Publication Details
    • Title: “Axillary Dissection vs No Axillary Dissection in Women with Sentinel Node Metastasis”
    • Journal: JAMA
    • Year: 2011
    • DOI: 10.1001/jama.2011.90
  3. Study Design
    • Phase III, randomized controlled, non-inferiority trial
  4. Patient Population
    • Women with T1–T2 invasive breast cancer and 1–2 positive sentinel lymph nodes undergoing lumpectomy and radiation
  5. Number of Patients
    • Total: 891
  • SLNB alone: 446
  • SLNB + ALND: 445
  1. Interventions Compared
    • SLNB alone vs SLNB + full ALND
  2. Primary and Secondary Endpoints
    • Primary: Overall survival
    • Secondary: DFS, locoregional recurrence, complications
  3. Key Findings
    • No difference in OS or DFS; less lymphedema with SLNB alone
  4. Impact on Clinical Practice
    • Reduced need for ALND in selected patients; modernized axillary management
  5. Trial Sponsor / Group
    • Sponsor: American College of Surgeons Oncology Group (ACOSOG)
  1. Trial Name / Acronym
    NSABP B‑06
  2. Publication Details
    • Title: “Eight-Year Results of the NSABP B‑06 Randomized Trial of Total Mastectomy versus Lumpectomy with or without Irradiation”
    • Journal: NEJM
    • Year: 1985
    • DOI: 10.1056/NEJM198503143121101
  3. Study Design
    • Phase III, randomized controlled trial
    • Multicenter, open-label
  4. Patient Population
    • Women with stage I or II invasive breast cancer
    • Tumor ≤4 cm, suitable for breast conservation
  5. Number of Patients
    • Total: 1,851
  • Total mastectomy: 628
  • Lumpectomy: 629
  • Lumpectomy + radiation: 594
  1. Interventions Compared
    • Total mastectomy vs lumpectomy vs lumpectomy + whole breast radiation
  2. Primary and Secondary Endpoints
    • Primary: Overall survival
    • Secondary: Disease-free survival, local recurrence
  3. Key Findings
    • No difference in OS among three groups
    • Lower local recurrence with lumpectomy + radiation vs lumpectomy alone
  4. Impact on Clinical Practice
    • Established breast-conserving therapy + radiation as standard for early-stage breast cancer
  5. Trial Sponsor / Group
    • Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)

Table Of Content

  • ATAC (Arimidex, Tamoxifen, Alone or in Combination)
    • Compared anastrozole vs tamoxifen
    • Key in establishing aromatase inhibitors in postmenopausal women.
  • TAM (NSABP B-14)
    • Established tamoxifen benefit in ER+ breast cancer.
  • SOFT & TEXT
    • Role of ovarian suppression with tamoxifen or exemestane in premenopausal women.
  • TAILORx
    • Validated use of the Oncotype DX recurrence score to guide adjuvant chemo in ER+/HER2– early-stage disease.
  • RxPONDER
    • Examined recurrence score-guided chemo in node-positive HR+ patients.
    • Found postmenopausal women with low scores can skip chemo.
  • NSABP B-31 & NCCTG N9831
    • Established trastuzumab in early-stage HER2+ disease.
  • APHINITY
    • Benefit of adding pertuzumab to trastuzumab and chemo in early-stage, node-positive HER2+ disease.
  • KATHERINE
    • T-DM1 (ado-trastuzumab emtansine) vs trastuzumab in patients with residual disease post-neoadjuvant therapy.
  • KRISTINE
    • Evaluated neoadjuvant T-DM1 + pertuzumab vs standard chemo + trastuzumab/pertuzumab.

 

  • KEYNOTE-522
  • Showed benefit of adding pembrolizumab (anti–PD-1) to neoadjuvant chemo in early TNBC.
  • IMpassion130
  • First to show survival benefit with atezolizumab + nab-paclitaxel in metastatic PD-L1+ TNBC.
  • CREATE-X
  • Showed capecitabine improves survival in TNBC patients with residual disease after neoadjuvant chemo.
  • OlympiA
  • Evaluated adjuvant olaparib in germline BRCA-mutated, high-risk HER2-negative breast cancer.
  • PALOMA, MONALEESA, MONARCH Trials
  • Established CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) with endocrine therapy.
  • SOLAR-1
  • Evaluated alpelisib (PI3K inhibitor) + fulvestrant in PIK3CA-mutant HR+ MBC.
  • EMERALD
  • Showed efficacy of elacestrant, an oral SERD, in ESR1-mutant breast cancer.
  • MINDACT
  • Used MammaPrint genomic assay to guide adjuvant chemotherapy decisions.
  • ACOSOG Z0011
  • Changed axillary management by showing no survival benefit from ALND in certain node-positive patients after lumpectomy and radiation.
  • NSABP B-06
  • Landmark trial that established lumpectomy + radiation = mastectomy for early-stage disease.

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