Landmark trials in the medical oncology management of metastatic breast cancer

Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer

(2021) Hope S. Rugo et al.   JAMA Oncology

Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study

(2021) Hope S Rugo et al.   LANCET ONCOLOGY

Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer

(2021) Aditya Bardia et al.   NEW ENGLAND JOURNAL OF MEDICINE

Evaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysis

(2020) Noman Paracha et al.   BREAST CANCER RESEARCH AND TREATMENT

Cancer statistics, 2020

(2020) Rebecca L. Siegel et al.   CA-A CANCER JOURNAL FOR CLINICIANS

Cyclin-dependent kinase 4 and 6 inhibitors for hormone receptor-positive breast cancer: past, present, and future

(2020) Laura M Spring et al.   LANCET

TBCRC 048: A phase II study of olaparib monotherapy in metastatic breast cancer patients with germline or somatic mutations in DNA damage response (DDR) pathway genes (Olaparib Expanded).

(2020) Nadine M. Tung et al.   JOURNAL OF CLINICAL ONCOLOGY

KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer.

(2020) Javier Cortes et al.   JOURNAL OF CLINICAL ONCOLOGY

PARSIFAL: A randomized, multicenter, open-label, phase II trial to evaluate palbociclib in combination with fulvestrant or letrozole in endocrine-sensitive patients with estrogen receptor (ER)[+]/HER2[-] metastatic breast cancer.

(2020) Antonio Llombart-Cussac et al.   JOURNAL OF CLINICAL ONCOLOGY

A randomized phase III trial of systemic therapy plus early local therapy versus systemic therapy alone in women with de novo stage IV breast cancer: A trial of the ECOG-ACRIN Research Group (E2108).

(2020) Seema Ahsan Khan et al.   JOURNAL OF CLINICAL ONCOLOGY

ESR1 mutations and overall survival on fulvestrant versus exemestane in advanced hormone receptor positive breast cancer: A combined analysis of the phase III SoFEA and EFECT trials

(2020) Nicholas C. Turner et al.   CLINICAL CANCER RESEARCH

Antibody–drug conjugates in breast cancer: the chemotherapy of the future?

(2020) Eleonora Nicolò et al.   CURRENT OPINION IN ONCOLOGY

Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial

(2020) Cristina Saura et al.   JOURNAL OF CLINICAL ONCOLOGY

LBA16 IMpassion130: Final OS analysis from the pivotal phase III study of atezolizumab + nab-paclitaxel vs placebo + nab-paclitaxel in previously untreated locally advanced or metastatic triple-negative breast cancer

(2020) L.A. Emens et al.   ANNALS OF ONCOLOGY

LBA18 Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC)

(2020) F. André et al.   ANNALS OF ONCOLOGY

LBA15 Primary results from IMpassion131, a double-blind placebo-controlled randomised phase III trial of first-line paclitaxel (PAC) ± atezolizumab (atezo) for unresectable locally advanced/metastatic triple-negative breast cancer (mTNBC)

(2020) D.W. Miles et al.   ANNALS OF ONCOLOGY

Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer

(2019) Rita S. Mehta et al.   NEW ENGLAND JOURNAL OF MEDICINE

Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer

(2019) Aditya Bardia et al.   NEW ENGLAND JOURNAL OF MEDICINE

Immunotherapy and targeted therapy combinations in metastatic breast cancer

(2019) Francisco J Esteva et al.   LANCET ONCOLOGY

IMpassion130: updated overall survival (OS) from a global, randomized, double-blind, placebo-controlled, Phase III study of atezolizumab (atezo) + nab-paclitaxel (nP) in previously untreated locally advanced or metastatic triple-negative breast cancer (mTNBC).

(2019) Peter Schmid et al.   JOURNAL OF CLINICAL ONCOLOGY

End-of-study analysis from the phase III, randomized, double-blind, placebo (Pla)-controlled CLEOPATRA study of first-line (1L) pertuzumab (P), trastuzumab (H), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer (MBC).

(2019) Sandra M. Swain et al.   JOURNAL OF CLINICAL ONCOLOGY

Alpelisib for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer

(2019) Fabrice André et al.   NEW ENGLAND JOURNAL OF MEDICINE

Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2–positive advanced breast cancer: Final results from MARIANNE

(2019) Edith A. Perez et al.   CANCER

Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer

(2019) Seock-Ah Im et al.   NEW ENGLAND JOURNAL OF MEDICINE

Fulvestrant Plus Vistusertib vs Fulvestrant Plus Everolimus vs Fulvestrant Alone for Women With Hormone Receptor–Positive Metastatic Breast Cancer

(2019) Peter Schmid et al.   JAMA Oncology

The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor–Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy—MONARCH 2

(2019) George W. Sledge et al.   JAMA Oncology

LBA21KEYNOTE-119: Phase III study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple negative breast cancer (mTNBC)

(2019) J Cortés et al.   ANNALS OF ONCOLOGY

Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair–Deficient Cancer: Results From the Phase II KEYNOTE-158 Study

(2019) Aurelien Marabelle et al.   JOURNAL OF CLINICAL ONCOLOGY

Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial

(2019) Peter Schmid et al.   LANCET ONCOLOGY

Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer

(2019) Dennis J. Slamon et al.   NEW ENGLAND JOURNAL OF MEDICINE

Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer

(2019) Rashmi K. Murthy et al.   NEW ENGLAND JOURNAL OF MEDICINE

Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer

(2019) Shanu Modi et al.   NEW ENGLAND JOURNAL OF MEDICINE

Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer

(2018) G N Hortobagyi et al.   ANNALS OF ONCOLOGY

Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01

(2018) Atilla Soran et al.   ANNALS OF SURGICAL ONCOLOGY

Overcoming endocrine resistance in hormone receptor–positive breast cancer

(2018) A. AlFakeeh et al.   Current Oncology

Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3

(2018) Dennis J. Slamon et al.   JOURNAL OF CLINICAL ONCOLOGY

Randomized Phase II Trial of Fulvestrant Plus Everolimus or Placebo in Postmenopausal Women With Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy: Results of PrE0102

(2018) Noah Kornblum et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA-mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER.

(2018) Jose Baselga et al.   JOURNAL OF CLINICAL ONCOLOGY

Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial

(2018) Debu Tripathy et al.   LANCET ONCOLOGY

Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial

(2018) Angelo Di Leo et al.   LANCET ONCOLOGY

Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial

(2018) Andrew Tutt et al.   NATURE MEDICINE

Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

(2018) Freddie Bray et al.   CA-A CANCER JOURNAL FOR CLINICIANS

Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation

(2018) Jennifer K. Litton et al.   NEW ENGLAND JOURNAL OF MEDICINE

Dual targeting of HER2-positive breast cancer with trastuzumab emtansine and pertuzumab: understanding clinical trial results

(2018) Alberto Ocaña et al.   Oncotarget

Pembrolizumab monotherapy for previously untreated, PD-L1-positive, metastatic triple-negative breast cancer: cohort B of the phase II KEYNOTE-086 study

(2018) S Adams et al.   ANNALS OF ONCOLOGY

Pembrolizumab monotherapy for previously treated metastatic triple-negative breast cancer: cohort A of the phase II KEYNOTE-086 study

(2018) S Adams et al.   ANNALS OF ONCOLOGY

Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer

(2018) Nicholas C. Turner et al.   NEW ENGLAND JOURNAL OF MEDICINE

Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer

(2018) Peter Schmid et al.   NEW ENGLAND JOURNAL OF MEDICINE

The efficacy of lapatinib and capecitabine in HER-2 positive breast cancer with brain metastases: A systematic review and pooled analysis

(2017) Fausto Petrelli et al.   EUROPEAN JOURNAL OF CANCER

MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2− Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy

(2017) George W. Sledge et al.   JOURNAL OF CLINICAL ONCOLOGY

MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer

(2017) Matthew P. Goetz et al.   JOURNAL OF CLINICAL ONCOLOGY

Trastuzumab Emtansine With or Without Pertuzumab Versus Trastuzumab Plus Taxane for Human Epidermal Growth Factor Receptor 2–Positive, Advanced Breast Cancer: Primary Results From the Phase III MARIANNE Study

(2017) Edith A. Perez et al.   JOURNAL OF CLINICAL ONCOLOGY

Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial

(2017) José Baselga et al.   LANCET ONCOLOGY

Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial

(2017) Miguel Martin et al.   LANCET ONCOLOGY

Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial

(2017) Véronique Diéras et al.   LANCET ONCOLOGY

Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial

(2017) Ian E Krop et al.   LANCET ONCOLOGY

Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation

(2017) Mark Robson et al.   NEW ENGLAND JOURNAL OF MEDICINE

Everolimus Plus Exemestane in Advanced Breast Cancer: Safety Results of the BALLET Study on Patients Previously Treated Without and with Chemotherapy in the Metastatic Setting

(2017) Daniele Generali et al.   ONCOLOGIST

DS-8201a, A Novel HER2-Targeting ADC with a Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising Antitumor Efficacy with Differentiation from T-DM1

(2016) Y. Ogitani et al.   CLINICAL CANCER RESEARCH

Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study

(2016) Rita Nanda et al.   JOURNAL OF CLINICAL ONCOLOGY

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

(2016) John F R Robertson et al.   LANCET

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer

(2016) Gabriel N. Hortobagyi et al.   NEW ENGLAND JOURNAL OF MEDICINE

Palbociclib and Letrozole in Advanced Breast Cancer

(2016) Richard S. Finn et al.   NEW ENGLAND JOURNAL OF MEDICINE

Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance)

(2015) Hope S. Rugo et al.   JOURNAL OF CLINICAL ONCOLOGY

CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer

(2015) Xavier Pivot et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase III Open-Label Randomized Study of Eribulin Mesylate Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

(2015) Peter A. Kaufman et al.   JOURNAL OF CLINICAL ONCOLOGY

Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial

(2015) Rajendra Badwe et al.   LANCET ONCOLOGY

The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study

(2015) Richard S Finn et al.   LANCET ONCOLOGY

Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

(2015) Sandra M. Swain et al.   NEW ENGLAND JOURNAL OF MEDICINE

Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†

(2014) M. Piccart et al.   ANNALS OF ONCOLOGY

Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial

(2014) Ian E Krop et al.   LANCET ONCOLOGY

Final Overall Survival: Fulvestrant 500 mg vs 250 mg in the Randomized CONFIRM Trial

(2013) A. D. Leo et al.   JNCI-Journal of the National Cancer Institute

Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study

(2013) Sandra M Swain et al.   LANCET ONCOLOGY

Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial

(2013) Stephen RD Johnston et al.   LANCET ONCOLOGY

Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: follow-up analysis from the randomized ‘FIRST’ study

(2012) John F. R. Robertson et al.   BREAST CANCER RESEARCH AND TREATMENT

The BOLERO-2 trial: the addition of everolimus to exemestane in the treatment of postmenopausal hormone receptor-positive advanced breast cancer

(2012) Julia A Beaver et al.   Future Oncology

FACT: An Open-Label Randomized Phase III Study of Fulvestrant and Anastrozole in Combination Compared With Anastrozole Alone As First-Line Therapy for Patients With Receptor-Positive Postmenopausal Breast Cancer

(2012) Jonas Bergh et al.   JOURNAL OF CLINICAL ONCOLOGY

Overall Survival Benefit With Lapatinib in Combination With Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Final Results From the EGF104900 Study

(2012) Kimberly L. Blackwell et al.   JOURNAL OF CLINICAL ONCOLOGY

Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer

(2012) Sunil Verma et al.   NEW ENGLAND JOURNAL OF MEDICINE

Incidence and Outcome of BRCA Mutations in Unselected Patients with Triple Receptor-Negative Breast Cancer

(2011) A. M. Gonzalez-Angulo et al.   CLINICAL CANCER RESEARCH

Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer

(2011) José Baselga et al.   NEW ENGLAND JOURNAL OF MEDICINE

Results of the CONFIRM Phase III Trial Comparing Fulvestrant 250 mg With Fulvestrant 500 mg in Postmenopausal Women With Estrogen Receptor–Positive Advanced Breast Cancer

(2010) Angelo Di Leo et al.   JOURNAL OF CLINICAL ONCOLOGY

Randomized Study of Lapatinib Alone or in Combination With Trastuzumab in Women With ErbB2-Positive, Trastuzumab-Refractory Metastatic Breast Cancer

(2010) Kimberly L. Blackwell et al.   JOURNAL OF CLINICAL ONCOLOGY

Lapatinib Plus Capecitabine in Women with HER-2-Positive Advanced Breast Cancer: Final Survival Analysis of a Phase III Randomized Trial

(2010) D. Cameron et al.   ONCOLOGIST

Overall survival benefit for weekly vs. three-weekly taxanes regimens in advanced breast cancer: A meta-analysis

(2009) Davide Mauri et al.   CANCER TREATMENT REVIEWS

Resistance to Trastuzumab in Breast Cancer

(2009) P. R. Pohlmann et al.   CLINICAL CANCER RESEARCH

Activity of Fulvestrant 500 mg Versus Anastrozole 1 mg As First-Line Treatment for Advanced Breast Cancer: Results From the FIRST Study

(2009) John F.R. Robertson et al.   JOURNAL OF CLINICAL ONCOLOGY

Trastuzumab Beyond Progression in Human Epidermal Growth Factor Receptor 2–Positive Advanced Breast Cancer: A German Breast Group 26/Breast International Group 03-05 Study

(2009) Gunter von Minckwitz et al.   JOURNAL OF CLINICAL ONCOLOGY