Trials · Topics · Breast Cancer
Breast Cancer clinical trials
135 Breast Cancer trials (Medical Oncology and Radiation Oncology) summarized for fellows and board review, newest first within each disease. Each summary covers design, results, toxicity and what changed in practice.
Jump to: RT in early stage · HR+ perioperative · HR+ advanced · TNBC perioperative · HER2+ advanced · HER2+ perioperative · TNBC advanced · DCIS · Prevention · HR+ HER2-low advanced
RT in early stage (30)
- DBCG Skagen trial 1 J Clin Oncol 2026For locoregional (including regional nodal) radiotherapy of high-risk breast cancer, 40 Gy in 15 fractions did not cause more arm lymphedema than 50 Gy in 25...
- EORTC 22922/10925 trial Lancet Oncol 2026In node-negative patients with central/medial tumors, IM-MS irradiation significantly reduced 20-year breast cancer mortality (HR 0.70), but the gain was offset by...
- HypoG-01 Lancet 2026HypoG-01 demonstrates that 40 Gy/15f locoregional RT is non-inferior to 50 Gy/25f for arm lymphedema, supporting hypofractionation when regional nodal irradiation is...
- NRG/RTOG 1005: Concurrent vs Sequential Boost in Early Breast Cancer J Clin Oncol 2026A concurrent boost delivered during 15-fraction hypofractionated WBI is non-inferior to the conventional sequential boost for ipsilateral breast recurrence and...
- SUPREMO Trial (10-Year Analysis) Radiotherapy and Oncology 2026SUPREMO 10-year results showed no OS benefit from PMRT to chest wall alone in low- to intermediate-risk disease. However, trial design limitations and evolving...
- SENOMAC NEJM 2024SLNB alone was non-inferior to ALND for short-term DFS in breast cancer patients with SLN macrometastasis, including mastectomy patients - extending the Z0011...
- FAST-Forward Lancet 202026Gy in 5 fractions over 1 week was non-inferior to 40Gy in 15 fractions for IBTR at 5 years and produced comparable or slightly better normal tissue outcomes....
- RAPID Lancet 2019APBI using 38.5Gy in 10 BID fractions was non-inferior to WBI for IBTR at 8 years. However, cosmetic outcomes were significantly worse with APBI - 35% had poor or...
- IBCSG 23-01 Lancet Oncol 2018Omitting ALND in patients with ≤1 positive sentinel node containing only micrometastasis did not compromise DFS or OS compared to complete ALND. IBCSG 23-01...
- Smith ASTRO WBI Guideline Pract Radiat Oncol 2018For women with invasive breast cancer undergoing WBI (with or without low axillary coverage), hypofractionated WBI is the preferred dose-fractionation scheme. The...
- TAILORx N Engl J Med 2018For women with HR+, HER2−, N0 breast cancer and RS 11-25, endocrine therapy alone is non-inferior to chemoendocrine therapy for most patients. The only exception was...
- ACOSOG Z0011 (10-Year Update) JAMA 2017At 10-year follow-up, SLNB alone remains non-inferior to completion ALND in patients with 1-2 positive SLNs undergoing BCS + WBI + adjuvant systemic therapy. ALND...
- Correa APBI ASTRO Consensus 2017 Pract Radiat Oncol 2017APBI is an acceptable alternative to whole breast irradiation in appropriately selected patients. Suitable patients are those with small, node-negative, ER+, unifocal...
- IMPORT LOW Lancet 2017APBI (40Gy/15f to partial breast) was non-inferior to whole-breast irradiation for IBTR in low-risk early BC patients after BCS, with similar or better normal tissue...
- GEC-ESTRO Lancet 2016Multicatheter brachytherapy APBI was non-inferior to whole-breast RT for local recurrence in selected low-to-intermediate-risk early BC. Treatment time was...
- EORTC 22922/10925 (Poortmans) N Engl J Med 2015Irradiation of the internal mammary and medial supraclavicular nodes provides a statistically significant improvement in DFS (absolute 3%) and a borderline...
- MA-20 N Engl J Med 2015Regional nodal irradiation (including IMN, SCV, and upper axillary nodes) added to whole breast RT improved 10-year DFS and distant DFS in women with node-positive or...
- AMAROS Lancet Oncol 2014Axillary RT is non-inferior to ALND in controlling axillary disease in patients with SLN-positive breast cancer, with significantly lower rates of lymphedema and arm...
- EBCTCG PMRT Meta-Analysis 2014 2014PMRT significantly reduces locoregional recurrence and improves 20-year breast cancer and overall survival in women with 1-3 positive nodes after mastectomy + ALND....
- Jagsi Z0011 Axillary Field Analysis J Clin Oncol 2014A substantial proportion of Z0011 patients received either deliberate nodal RT or inadvertent axillary coverage through high tangent fields. This axillary irradiation...
- SSO-ASTRO-ASCO Margins Guideline Invasive BC J Clin Oncol 2014For invasive breast cancer treated with BCS + whole breast RT with modern systemic therapy, "no ink on tumor" is the standard for an adequate margin. Routinely using...
- CALGB 9343 J Clin Oncol 2013Among women ≥70 with T1 ER+ breast cancer on tamoxifen, the absolute benefit of RT was a 7% reduction in locoregional recurrence at 10 years but with no improvement...
- START-B Lancet Oncol 201340Gy in 15 fractions was non-inferior to 50Gy in 25 fractions for local tumor control and produced significantly less late breast toxicity (induration, cosmetic...
- ACOSOG Z0011 JAMA 2011SLNB alone was non-inferior to ALND for OS and DFS in patients with 1-2 positive sentinel nodes undergoing BCS with whole-breast irradiation. ACOSOG Z0011...
- EBCTCG BCS RT Meta-Analysis 2011 2011Radiotherapy after BCS reduces 10-year any recurrence by ~16% and 15-year breast cancer mortality by ~4% in absolute terms. The 4:1 ratio (4 recurrences prevented per...
- Danish DBCG 82b/82c J Clin Oncol 2006Postmastectomy RT changes the long-term disease recurrence pattern in high-risk breast cancer: it reduces LRR from 49% to 14% at 18 years, and through prevention of...
- British Columbia RT RCT (Ragaz 20yr) J Natl Cancer Inst 2005At 20-year follow-up, postmastectomy locoregional RT (37.5 Gy/16 fx) added to CMF chemotherapy significantly improved all cancer endpoints, including overall survival...
- Taghian NSABP LRF Analysis J Clin Oncol 2004In node-positive patients treated with mastectomy and adjuvant chemotherapy but without PMRT, 10-year LRF rates range from 13% (1-3 nodes) to 32% (≥10 nodes). Even in...
- NSABP B-04 trial NEJM 2002Radical mastectomy offers no survival advantage over total mastectomy with or without RT, refuting the Halstedian rationale for extensive surgery.
- NSABP B-06 trial NEJM 2002Lumpectomy plus radiation yields equivalent survival to mastectomy with markedly reduced ipsilateral recurrence versus lumpectomy alone, establishing...
HR+ perioperative (26)
- Extended Endocrine Therapy (Premenopausal Cohort) Breast Cancer Research and Treatment 2024Extended endocrine therapy substantially improves DFS in high-risk ER+/HER2- early breast cancer, especially in patients with large tumors, node involvement, and high...
- NATALEE Ann Oncol 2024Adjuvant ribociclib + NSAI significantly improved iDFS versus NSAI alone across key subgroups including stage II/III and nodal status. OS data remain immature....
- monarchE JCO 2020Abemaciclib added to standard endocrine therapy significantly improved IDFS and DRFI in high-risk HR+ HER2- early breast cancer. The absolute IDFS benefit of ~6% at 4...
- TEXT/SOFT JCO 2023At 13-year follow-up, exemestane+OFS demonstrated superior DFS vs tamoxifen+OFS in premenopausal HR+ early BC. OFS added to tamoxifen significantly improved OS vs...
- PALLAS JCO 2022Palbociclib added to adjuvant endocrine therapy did not improve IDFS in HR+ HER2- early breast cancer. The trial was definitively negative, with overlapping IDFS...
- ABCSG-16 trial (SALSA) trial NEJM 2021No DFS or OS difference between 2 vs 5 additional years of anastrozole (i.e., 7 vs 10 total years of endocrine therapy); the longer duration increased fracture risk....
- PENELOPE-B JCO 2021Palbociclib added to endocrine therapy did not improve IDFS in HR+ HER2- early BC patients with residual disease after NACT. The trial was negative, providing no...
- RxPONDER NEJM 2021Postmenopausal women with HR+/HER2- N1 early BC and RS 0-25 derived no benefit from chemotherapy; ET alone is the standard of care. Premenopausal women with the same...
- IDEAL (BOOG 2006-05) trial JNCI 2018No DFS or OS difference between 2.5 vs 5 years of extended letrozole after an initial 5 years of endocrine therapy. Prolonged letrozole was associated with a ~1%...
- SOLE trial 2018Intermittent extended letrozole did not improve DFS over continuous therapy, with similar toxicity. Continuous extended letrozole remains the standard schedule...
- FACE trial JCO 2017Letrozole and anastrozole have similar efficacy and comparable safety as adjuvant therapy for postmenopausal HR+, node-positive breast cancer.
- MA.17R NEJM 2016Extended letrozole for 5 years after completing 5 years of aromatase inhibitor therapy significantly improved DFS and reduced contralateral breast cancer risk. OS was...
- MINDACT NEJM 2016Patients with clinical-high/genomic-low risk early BC had non-inferior 5-yr DMFS when chemotherapy was omitted, supporting the use of the 70-gene signature...
- Meta-analysis of AI vs TAM in early breast cancer 2015In postmenopausal women, 5yr of AI reduces 10-yr recurrence by ~30% and breast-cancer mortality by ~15% vs 5yr tamoxifen (and by ~40% vs no endocrine therapy). AI...
- SOFT trial NEJM 2015Adding OFS to tamoxifen did not significantly improve DFS overall, but provided meaningful benefit in higher-risk women (those warranting chemotherapy, especially age...
- TEXT trail NEJM 2014Among premenopausal women receiving OFS, exemestane reduced recurrence vs tamoxifen, with no OS difference. Benefit is most relevant for higher-risk patients (stage...
- ATLAS trial Lancet 2013Extending tamoxifen to 10 years reduces recurrence (3.7%) and breast cancer mortality (2.8%) versus 5 years, at the cost of increased PE and endometrial cancer risk.
- ATTOM trial JCO 201310 years of tamoxifen reduces breast cancer recurrence from year 7 onward and mortality after year 10, consistent with ATLAS, at the cost of increased endometrial cancer.
- NCIC CTG MA.27 trial JCO 2013Exemestane and anastrozole have equivalent efficacy as adjuvant therapy for postmenopausal HR+ breast cancer, with modestly different toxicity profiles (less lipid...
- ABCG 8 trial JCO 2012Switching to anastrozole after 2yr of tamoxifen significantly improved DRFS vs 5yr tamoxifen, supporting a sequential endocrine strategy in postmenopausal HR+ early...
- TEAM trial 2011Upfront exemestane and a sequential tamoxifen-to-exemestane strategy yielded equivalent 5-yr DFS and OS; both are acceptable adjuvant approaches, with toxicity...
- BIG 1-98 trial NEJM 2009Sequential letrozole-tamoxifen strategies and letrozole monotherapy yielded similar DFS; letrozole and tamoxifen monotherapy had similar OS. Sequencing did not...
- NSABP B-33 JCO 2008Extended adjuvant exemestane after 5 years of tamoxifen produced a significant improvement in RFS and a non-significant trend in DFS. Premature closure and...
- ITA trial JCO 2005Switching to anastrozole after 2-3yr of tamoxifen significantly improved EFS and RFS vs continued tamoxifen in node-positive postmenopausal HR+ patients.
- IES trial NEJM 2004Switching from tamoxifen to exemestane after 2-3 years improves DFS (but not OS) and reduces contralateral breast cancer and endometrial cancer compared with...
- ATAC trial Lancet 2002Adjuvant anastrozole improved DFS and reduced contralateral breast cancer vs tamoxifen in postmenopausal women, with fewer gynecologic and thrombotic events but more...
HR+ advanced (18)
- evERA trial 2026All-oral giredestrant + everolimus significantly prolonged PFS vs standard endocrine therapy + everolimus after prior CDK4/6 inhibitor, with the largest benefit in...
- SONIA Trial (CDK4/6i Timing Analysis) JAMA Oncology 2026First-line CDK4/6i did not improve OS vs second-line use in the overall population but increased toxicity and cost. A subgroup signal suggests OS benefit in...
- TBCRC 048 (Olaparib Expanded) Journal of Clinical Oncology 2026Olaparib monotherapy showed substantial activity in germline BRCA-mutated MBC and clinically meaningful (though suboptimal) activity in somatic-mutation carriers...
- SONIA Trial (ctDNA Biomarker Analysis) Nature Medicine 2025Pretreatment ctDNA levels identified patients benefiting from first-line CDK4/6i (high ctDNA) versus second-line use (low ctDNA), demonstrating a potential...
- INAVO120 NEJM 2024Adding inavolisib to palbociclib + fulvestrant approximately doubled PFS in PIK3CA-mutated HR+ HER2- mBC in the early-relapse adjuvant setting. The triplet represents...
- TROPION-Breast01 J Clin Oncol 2024Dato-DXd produced a statistically significant, clinically meaningful PFS improvement over investigator's choice chemotherapy with a more favorable grade ≥3 toxicity...
- CAPItello-291 NEJM 2023Capivasertib + fulvestrant significantly improved PFS vs fulvestrant alone after prior AI/CDK4/6i, with greater benefit in the AKT pathway-altered subgroup....
- PALOMA-2 JCO 2024Palbociclib + letrozole significantly improved PFS vs letrozole alone in first-line postmenopausal HR+ HER2- mBC but failed to demonstrate an OS benefit at final...
- TROPiCS-02 JCO 2022Sacituzumab govitecan significantly improved PFS and OS vs chemotherapy in heavily pretreated HR+ HER2- mBC, becoming the first ADC to demonstrate an OS benefit in...
- EMERALD JCO 2022Elacestrant significantly improved PFS vs standard ET in ER+ HER2- mBC after CDK4/6 inhibitor, with greatest benefit in the ESR1-mutated subgroup. Oral dosing and...
- MONALEESA-2 Ann Oncol 2022Ribociclib + letrozole significantly improved both PFS and OS vs letrozole alone in postmenopausal HR+ HER2- mBC, with an OS benefit of ~12.5 months. MONALEESA-2...
- MONARCH-3 JCO 2017Abemaciclib + NSAI significantly improved PFS in first-line postmenopausal HR+ HER2- mBC. OS was numerically improved at 5-year follow-up but not statistically...
- PALOMA-3 Ann Oncol 2021Palbociclib + fulvestrant significantly improved PFS in HR+ HER2- mBC after prior endocrine therapy. OS did not reach statistical significance at final analysis (34.9...
- MONALEESA-3 NEJM 2020Ribociclib + fulvestrant significantly improved OS vs placebo + fulvestrant in postmenopausal HR+ HER2- advanced BC across first and second line, with a 12-month OS...
- MONARCH-2 JCO 2017Abemaciclib + fulvestrant significantly improved both PFS and OS vs fulvestrant alone in HR+ HER2- mBC after prior endocrine therapy, with a 9.4-month OS gain....
- MONALEESA-7 NEJM 2019Ribociclib + OFS + endocrine therapy significantly improved PFS and OS in premenopausal HR+ HER2- advanced BC, representing the first CDK4/6 inhibitor trial to show...
- SOLAR-1 NEJM 2019Alpelisib + fulvestrant significantly improved PFS in PIK3CA-mutated HR+ HER2- advanced BC after prior ET. Validated PI3Kα inhibition as a biomarker-driven strategy....
- BOLERO-2 NEJM 2012Everolimus + exemestane significantly improved PFS vs exemestane alone in postmenopausal HR+ HER2- mBC refractory to NSAI - the first mTOR inhibitor combination...
TNBC perioperative (18)
- NSABP B-59/GeparDouze trial Nat Med 2026Adding atezolizumab to an anthracycline/taxane/carboplatin neoadjuvant regimen did not significantly improve EFS in stage II-III TNBC. This contrasts with the...
- OlympiA (6-year update) Ann Oncol 2026At 6.1 years, 1 year of adjuvant olaparib maintained clinically meaningful IDFS, DDFS, and OS benefits in gBRCA1/2-mutated high-risk HER2-negative early breast...
- PEARLY trial Ann Oncol 2026Adding carboplatin to standard anthracycline→taxane (neo)adjuvant chemotherapy significantly improved EFS in early-stage TNBC, with a manageable, predominantly...
- SUBITO trial Lancet Oncol 2026Intensified chemotherapy with autologous stem-cell rescue provided no overall-survival advantage over conventional chemotherapy plus olaparib in stage III...
- A-BRAVE Ann Oncol 2025A-BRAVE did not meet its primary endpoint of DFS improvement with adjuvant avelumab in high-risk early TNBC (HR 0.81, P=.172). A descriptive OS signal (HR 0.66, 3-yr...
- KEYNOTE-522 NEJM 2022Pembrolizumab + neoadjuvant chemotherapy → adjuvant pembrolizumab significantly improved both pCR (by ~14%) and EFS (HR 0.63) in early TNBC. EFS and emerging OS...
- OlympiA NEJM 2021Adjuvant olaparib for 1 year significantly improved IDFS and OS in gBRCA-mutated HER2-negative early breast cancer patients who had completed standard chemotherapy....
- GEICAM/2003-11_CIBOMA/2004-01 trial JCO 2020Extended adjuvant capecitabine after standard chemotherapy did not significantly improve DFS in early TNBC overall. An exploratory benefit in the non-basal phenotype...
- IMpassion031 Lancet 2020Atezolizumab + nab-paclitaxel → AC-based NACT significantly improved pCR in early TNBC (ITT), with greater benefit in PD-L1-positive tumors. IMpassion031 demonstrated...
- BrighTNess Lancet Oncol 2018Carboplatin significantly increased pCR rates in TNBC when added to paclitaxel/AC-based NACT (~27% absolute improvement). Veliparib did not add to carboplatin's...
- CALOR trial JCO 2018Adjuvant chemotherapy after excision of isolated locoregional recurrence significantly improves DFS in ER-negative disease but provides no clear benefit in...
- CREATE-X NEJM 2017Adjuvant capecitabine significantly improved DFS and OS vs observation in HER2-negative early BC with residual disease after NACT, with the greatest benefit in the...
- CALGB 40603 (Alliance) trial 2015Adding carboplatin to neoadjuvant chemotherapy significantly raises pCR in TNBC; bevacizumab also increases pCR but with added toxicity and no clear long-term role....
- CALGB 40101 trial JCO 2012Prolonging AC or single-agent paclitaxel from 4 to 6 cycles does not improve DFS or OS; 4 cycles is sufficient.
- USORTC-9735 trial JCO 2006Adjuvant TC provides superior DFS and OS versus AC, establishing an effective anthracycline-free option.
- CALGB 9344 trial JCO 2003Adding sequential paclitaxel after AC significantly improves DFS and OS in node-positive breast cancer; escalating doxorubicin above 60 mg/m2 confers no benefit.
- CALGB 9741 trial JCO 2003Dose-dense (q2wk) adjuvant chemotherapy with filgrastim reduces recurrence (26% relative) and death (31% relative) versus conventional q3wk dosing; sequence does not...
- NSABP-B15 trial JCO 1990AC x4 is equivalent to CMF x6 with greater convenience and shorter duration, establishing AC as a backbone of adjuvant chemotherapy in node-positive breast cancer.
HER2+ advanced (13)
- HORIZON-Breast01 trial Lancet Oncol 2026Trastuzumab rezetecan more than tripled median PFS versus pyrotinib plus capecitabine in previously treated HER2-positive metastatic breast cancer, with a distinct...
- PATINA (Palbociclib + HER2-Directed + Endocrine) New England Journal of Medicine 2026Adding palbociclib to maintenance anti-HER2 and endocrine therapy significantly improved PFS (15+ months) in HR+/HER2+ MBC, consolidating the CDK4/6 inhibitor role in...
- Trastuzumab Botidotin vs T-DM1 (HER2+ MBC) J Clin Oncol 2026Trastuzumab botidotin more than doubled PFS versus T-DM1 (11.1 vs 4.4 mo; HR 0.39) with a higher objective response rate in previously treated HER2-positive advanced...
- DESTINY-Breast09 NEJM 2025T-DXd + pertuzumab significantly improved PFS vs THP (HR 0.56; 40.7 vs 26.9mo), the largest PFS improvement demonstrated in first-line HER2-positive mBC. OS data awaited.
- HER2CLIMB-05 Journal of Clinical Oncology 2025Adding tucatinib to dual HER2 blockade significantly improved PFS in first-line maintenance for HER2+ MBC (HR 0.641), with a manageable safety profile and no new...
- DESTINY-Breast02 Lancet 2023T-DXd significantly improved PFS (HR 0.36) and OS (~13-month gain) vs chemotherapy in HER2+ mBC after T-DM1 treatment. DESTINY-Breast02 confirmed T-DXd's robust...
- Destiny Breast - 04 2022In HER2-low metastatic breast cancer, trastuzumab deruxtecan significantly prolonged progression-free and overall survival versus physician's choice chemotherapy...
- DESTINY-Breast03 NEJM 2022T-DXd demonstrated a dramatically superior PFS (HR 0.33) and OS benefit vs T-DM1 in HER2+ mBC after prior trastuzumab and taxane. DESTINY-Breast03 represents one of...
- SOPHIA JAMA Oncol 2021In heavily pretreated HER2+ advanced breast cancer, margetuximab + chemotherapy gave a statistically significant but small PFS gain over trastuzumab + chemotherapy...
- Destiny Breast - 01 trial 2020Trastuzumab deruxtecan produced durable responses in heavily pretreated HER2-positive metastatic breast cancer after T-DM1. Interstitial lung disease, including fatal...
- MARIANNE JCO 2017T-DM1 ± pertuzumab was not superior to trastuzumab + taxane in first-line HER2+ mBC. MARIANNE was definitively negative for both T-DM1 arms vs control, establishing...
- CLEOPATRA NEJM 2015Pertuzumab + trastuzumab + docetaxel (THP) significantly improved both PFS (6-month gain) and OS (~16-month gain) vs trastuzumab + docetaxel in first-line HER2+ mBC....
- EMILIA NEJM 2012T-DM1 significantly improved both PFS and OS compared to lapatinib + capecitabine in HER2+ mBC after trastuzumab and taxane, while demonstrating a superior...
HER2+ perioperative (9)
- Anbenitamab + HB1801 neoadjuvant HER2+ breast trial JAMA Oncol 2026Neoadjuvant anbenitamab + HB1801 significantly improved total pCR over standard THP without increased toxicity in early HER2-positive breast cancer - a positive...
- HLX11 pertuzumab biosimilar Clin Cancer Res 2026Neoadjuvant HLX11 met prespecified equivalence criteria versus reference pertuzumab for BICR-assessed tpCR (46.3% vs 45.8%; RR 1.01), with comparable secondary...
- neoCARHP Journal of Clinical Oncology 2026Taxane + dual HER2 blockade without carboplatin provided noninferior pCR and superior tolerability. Omitting carboplatin is applicable in HER2+ early breast cancer....
- DESTINY-Breast05 NEJM 2026T-DXd significantly improved IDFS compared to T-DM1 in HER2+ early BC with residual disease after NACT, with a 36% relative risk reduction and ~5% absolute benefit at...
- APHINITY JCO 2021Dual HER2 blockade (pertuzumab + trastuzumab) significantly improved IDFS vs trastuzumab alone in adjuvant HER2+ early BC, primarily benefiting node-positive...
- ExteNET Lancet Oncol 2017Neratinib significantly improved IDFS at 5 years in HER2+ early BC following trastuzumab-based adjuvant therapy, with the greatest benefit in the HR+/HER2+ subgroup....
- KATHERINE NEJM 2019T-DM1 significantly improved IDFS vs trastuzumab in HER2+ early BC with residual disease after NACT, reducing the relative risk of recurrence or death by 50%. The...
- Tailor-X NEJM 2018In HR+, HER2-, node-negative breast cancer with RS 11-25, endocrine therapy alone is noninferior to chemo-endocrine therapy. Chemotherapy may benefit women ≤50yr with...
- NeoSphere Lancet Oncol 2012Adding pertuzumab to trastuzumab + docetaxel significantly increased pCR rate in HER2+ early BC. NeoSphere provided the pivotal pCR data supporting pertuzumab's...
TNBC advanced (9)
- ASCENT-04/KEYNOTE-D19 NEJM 2026SG + pembrolizumab significantly improved PFS vs chemotherapy + pembrolizumab in PD-L1 CPS≥10 mTNBC (HR 0.65), with substantially lower discontinuation (12% vs 31%)...
- CAPItello-290 trial Ann Oncol 2026Adding capivasertib to first-line paclitaxel did not improve OS in metastatic TNBC, either overall or in PIK3CA/AKT1/PTEN-altered tumours, despite a numerical PFS...
- TROPION-Breast02 trial Ann Oncol 2026First phase III trial to show a significant PFS and OS benefit for a TROP2 ADC over chemotherapy in first-line, immunotherapy-ineligible advanced TNBC. ~5-month...
- KEYNOTE-355 NEJM 2022Pembrolizumab + chemotherapy significantly improved OS in patients with PD-L1 CPS ≥10 metastatic TNBC, establishing a new standard of care in this biomarker-selected...
- ASCENT NEJM 2021Sacituzumab govitecan significantly improved both PFS (HR 0.41) and OS (HR 0.48) vs chemotherapy in heavily pretreated metastatic TNBC - one of the largest hazard...
- KEYNOTE-119 Lancet Oncol 2021Pembrolizumab monotherapy did not improve OS vs chemotherapy in 2nd/3rd-line mTNBC in any PD-L1 subgroup. Definitively negative - pembrolizumab alone is not effective...
- EMBRACA NEJM 2018Talazoparib significantly improved PFS (HR 0.54) and ORR with better patient-reported QoL vs chemotherapy in gBRCA1/2-mutated HER2-negative mBC. OS was not...
- IMpassion130 NEJM 2018Atezolizumab + nab-paclitaxel showed significant PFS benefit in PD-L1+ mTNBC and a clinically meaningful but statistically marginal OS benefit (did not cross α...
- OlympiAD NEJM 2017Olaparib significantly improved PFS and ORR vs chemotherapy in gBRCA1/2-mutated HER2-negative mBC. OS was not significantly improved, though crossover and...
DCIS (5)
- Moran DCIS Tumor Bed Boost Meta-Analysis JAMA Oncol 2017A tumor bed boost after WBI for DCIS reduces IBTR, particularly in higher-risk patients (younger age, high nuclear grade, close/positive margins). The absolute...
- ECOG 5194 JCO 2015In highly selected DCIS patients - grade 1-2 with small lesions and adequate margins - the 12-year IBE with observation alone was approximately 14%, roughly half of...
- NSABP B-35 Lancet 2016Anastrozole significantly improved breast cancer-free interval compared to tamoxifen in postmenopausal women with hormone-receptor-positive DCIS after BCS, with the...
- SSO-ASTRO-ASCO Margins Guideline DCIS J Clin Oncol 2016For DCIS treated with BCS followed by whole breast RT, a minimum margin of 2 mm is associated with the lowest IBTR rates and is recommended. Wider margins (>2 mm) do...
- RTOG 98-04 J Clin Oncol 2015For patients with low-to-intermediate nuclear grade DCIS meeting strict criteria, RT reduced the 7-year IBE rate from 6.7% to 0.9% (absolute reduction ~6%, relative...
Prevention (5)
- BRCA Prophylactic Mastectomy (ON-BRCA II) Breast Cancer Research 2026Although no difference in overall CBC risk between BRCA1 and BRCA2 carriers, correspondence analysis revealed distinct pathologic predictors. Young BRCA1 carriers...
- IBIS-II Lancet 2020Anastrozole reduced breast cancer incidence by 47% over 10 years in high-risk postmenopausal women, with the benefit concentrated in ER-positive BC. IBIS-II...
- IBIS-I Lancet Oncol 2015Tamoxifen reduced breast cancer incidence by approximately 29% at 16-year follow-up in high-risk women. The benefit persists beyond the 5-year treatment period...
- MAP.3 NEJM 2011Exemestane reduced invasive breast cancer incidence by 65% vs placebo in postmenopausal high-risk women, with a 53% reduction in all BC. MAP.3, alongside IBIS-II...
- STAR (P-2) Cancer Prev Res 2010Tamoxifen and raloxifene have broadly similar efficacy for invasive BC prevention, though tamoxifen is more effective for DCIS/non-invasive BC. Raloxifene has a...
HR+ HER2-low advanced (2)
- DESTINY-Breast06 NEJM 2024T-DXd significantly improved PFS vs endocrine therapy as post-endocrine-therapy treatment in HER2-low HR+ mBC, supporting earlier-line use of T-DXd and further...
- DESTINY-Breast04 NEJM 2022T-DXd significantly improved PFS and OS vs chemotherapy in HER2-low HR+ and overall metastatic BC, redefining HER2-low (IHC 1+/2+ ISH-) as an actionable target....