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Neoplasms, BreastPhase 3NCT01160211

A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

A Phase 3 study testing Lapatinib, Trastuzumab and Aromatase Inhibitor in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 110 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
Lapatinib, Trastuzumab and Aromatase Inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
369 participants
Where
110 sitesin 29 countries
Study dates
5 May 2011to 6 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects eligible for enrollment in the study must meet all of the following criteria:
  • Signed written informed consent. In Korea and Japan, subjects between >=18 and <20 years of age must also have a legal representative sign the written informed consent.
  • Post-menopausal female subjects >=18 years of age. Post-menopausal as defined by any of the following:
  • Subjects at least 60 years of age.
  • Subjects under 60 years of age and amenorrhic for at least 12 consecutive months AND follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range (utilizing ranges from the local laboratory facility).
  • Prior bilateral oophorectomy.
Show all 19Show fewer
  • Prior radiation castration with amenorrhea for at least 6 months
  • Subjects must have a history of histologically confirmed breast cancer, with a clinically confirmed diagnosis of metastatic disease [confirmed by histology, cytology or other clinical means (e.g. CT, MRI)]. Subjects may have either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Tumors that are ER+ and/or PgR+ by local laboratory
  • Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as:
  • 3+ by Immunohistochemistry (IHC) and/or
  • HER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥2.0]
  • Subject must have received at least one prior regimen containing trastuzumab in combination with chemotherapy for breast cancer:.
  • Subject has ONLY received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment. OR
  • Subject has received ONE prior trastuzumab-containing regimen for metastatic disease (and has progressed), and may or may not have received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment.
  • Subject must have received prior endocrine therapy (such as aromatase inhibitors or selective estrogen receptor modulators). 8. Subjects who have a life expectancy of > 6 months as assessed by the treating investigator
  • 9. Subjects must have baseline Left Ventricular Ejection Fraction (LVEF) ≥50% measured by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) 10. Subject must have an ECOG performance status of 0-1 11. All prior treatment related toxicities must be CTCAE (Version 4.0) ≤ Grade 1 at the time of randomization 12. Completion of screening assessments 13. Adequate baseline organ function. 14. Subjects must meet all of the following criteria:
  • QTc <450msec or
  • QTc <480msec for subjects with bundle branch block The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB) or to Fridericia's formula (QTcF), machine or manual over read, for males and females. The specific formula that will be used in a protocol should be determined prior to initiation of the study, and the formula used to determine inclusion and discontinuation should be the same throughout the study. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period

Who cannot join

  • History of another malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or the disease is considered by the investigator to be rapidly progressing or life threatening (subjects who are intended for chemotherapy)
  • Serious cardiac illness or medical condition including but not confined to:
  • Uncontrolled arrhythmias
  • Uncontrolled or symptomatic angina
  • History of congestive heart failure (CHF)
Show all 14Show fewer
  • Documented myocardial infarction <6 months from study entry
  • Known history of, or clinical evidence of, central nervous system (CNS) metastases or leptomeningeal carcinomatosis
  • Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with the exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
  • Have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients that, in the opinion of the Investigator or GSK medical monitor, contraindicates their participation
  • Any prohibited medication.
  • Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.

Trial locations and contacts

110 sites in 29 countries.

110 sites in 29 countries

Argentina11 sites

  • Novartis Investigative Site

    Berazategui, Buenos Aires, B1880BBF

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, C1417DTN

  • Novartis Investigative Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB

  • Novartis Investigative Site

    Córdoba, X5004FHP

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1920CMK

  • Novartis Investigative Site

    La Rioja, F5300COE

  • Novartis Investigative Site

    Quilmes, 1878

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, T4000IAK

  • Novartis Investigative Site

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

Brazil8 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

  • Novartis Investigative Site

    Goiânia, Goiás, 74605-070

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Novartis Investigative Site

    Rio de Janeiro, 20560-120

  • Novartis Investigative Site

    São Paulo, São Paulo, 01317-001

  • Novartis Investigative Site

    São Paulo, São Paulo, 03102-002

  • Novartis Investigative Site

    São Paulo, São Paulo, 05651-901

Other trials in Brazil

Hungary8 sites

  • Novartis Investigative Site

    Győr, H-9024

  • Novartis Investigative Site

    Gyula, 5700

  • Novartis Investigative Site

    Kaposvár, 7400

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Nyíregyháza, 4400

  • Novartis Investigative Site

    Pécs, 7624

  • Novartis Investigative Site

    Szeged, 6720

  • Novartis Investigative Site

    Zalaegerszeg, H-8900

Other trials in Hungary

Japan7 sites

  • Novartis Investigative Site

    Aichi, 464-8681

  • Novartis Investigative Site

    Chiba, 277-8577

  • Novartis Investigative Site

    Ehime, 791-0280

  • Novartis Investigative Site

    Osaka, 537-8511

  • Novartis Investigative Site

    Osaka, 540-0006

  • Novartis Investigative Site

    Saitama, 362-0806

  • Novartis Investigative Site

    Tokyo, 104-8560

Other trials in Japan

Russia6 sites

  • Novartis Investigative Site

    Arkhangelsk, 163045

  • Novartis Investigative Site

    Kazan', 420029

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Ryazan, 390011

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197758

Other trials in Russia

Ukraine6 sites

  • Novartis Investigative Site

    Chernivtsi, 58013

  • Novartis Investigative Site

    Kharkiv, 61070

  • Novartis Investigative Site

    Liutizh, 07352

  • Novartis Investigative Site

    Sumy, 40005

  • Novartis Investigative Site

    Uzhhorod, 88000

  • Novartis Investigative Site

    Vinnitsia, 21029

Other trials in Ukraine

China5 sites

  • Novartis Investigative Site

    Changchun, Jilin, 130021

  • Novartis Investigative Site

    Fuzhou, Fujian, 350001

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510060

  • Novartis Investigative Site

    Harbin, 150081

  • Novartis Investigative Site

    Shanghai, 200032

Other trials in China

Germany5 sites

  • Novartis Investigative Site

    Fürstenwalde, Brandenburg, 15517

  • Novartis Investigative Site

    Goslar, Lower Saxony, 38642

  • Novartis Investigative Site

    Munich, Bavaria, 81675

  • Novartis Investigative Site

    Troisdorf, North Rhine-Westphalia, 53840

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551

Other trials in Germany

United States4 sites

  • Novartis Investigative Site

    Augusta, Georgia, 30912

  • Novartis Investigative Site

    Germantown, Tennessee, 38138

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Tacoma, Washington, 98405

Other trials in United States

Bulgaria4 sites

  • Novartis Investigative Site

    Plovdiv, 4004

  • Novartis Investigative Site

    Sofia, 1330

  • Novartis Investigative Site

    Sofia, 1756

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

South Korea4 sites

  • Novartis Investigative Site

    Gyeonggi-do, 10408

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 05505

  • Novartis Investigative Site

    Seoul, 06351

Other trials in South Korea

Spain4 sites

  • Novartis Investigative Site

    A Coruña, 15009

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Castellon, 12002

  • Novartis Investigative Site

    Madrid, 28040

Other trials in Spain

France3 sites

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Montpellier, 34298

  • Novartis Investigative Site

    Paris, 75970

Other trials in France

Greece3 sites

  • Novartis Investigative Site

    Alexandroupoli, 68100

  • Novartis Investigative Site

    Chania, 73100

  • Novartis Investigative Site

    Heraklion, 71110

Other trials in Greece

Hong Kong3 sites

  • Novartis Investigative Site

    Hong Kong

  • Novartis Investigative Site

    Kowloon

  • Novartis Investigative Site

    Tuenmen

Other trials in Hong Kong

Israel3 sites

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Ramat Gan, 52621

Other trials in Israel

Taiwan3 sites

  • Novartis Investigative Site

    Changhua, 500

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    Taipei, 11217

Other trials in Taiwan

United Kingdom3 sites

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    Maidstone, ME16 9QQ

  • Novartis Investigative Site

    Peterborough, PE3 9GZ

Other trials in United Kingdom

Australia2 sites

  • Novartis Investigative Site

    Albury, 2640

  • Novartis Investigative Site

    Douglas, 4814

Other trials in Australia

Belgium2 sites

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Namur, 5000

Other trials in Belgium

Croatia2 sites

  • Novartis Investigative Site

    Osijek, 31000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

India2 sites

  • Novartis Investigative Site

    Nagpur, 440010

  • Novartis Investigative Site

    New Delhi, 110 092

Other trials in India

Peru2 sites

  • Novartis Investigative Site

    Arequipa

  • Novartis Investigative Site

    Lima, Lima 18

Other trials in Peru

Poland2 sites

  • Novartis Investigative Site

    Konin, 62-500

  • Novartis Investigative Site

    Warsaw, 04-125

Other trials in Poland

Portugal2 sites

  • Novartis Investigative Site

    Lisbon, 1400-038

  • Novartis Investigative Site

    Porto, 4200-072

Other trials in Portugal

Serbia2 sites

  • Novartis Investigative Site

    Belgrade, 11000

  • Novartis Investigative Site

    Kamenitz, 21204

Other trials in Serbia

Turkey (Türkiye)2 sites

  • Novartis Investigative Site

    Ankara, 06200

  • Novartis Investigative Site

    Izmir, 35100

Other trials in Turkey (Türkiye)

Italy1 site

  • Novartis Investigative Site

    Rozzano (MI), Lombardy, 20089

Other trials in Italy

Singapore1 site

  • Novartis Investigative Site

    Singapore, 308433

Other trials in Singapore

About this study

Official title: A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies

A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

Read the detailed description

This Phase III, multicenter, open-label study randomized subjects to one of the three treatment arms:

  1. Treatment group A: lapatinib 1000 mg PO once daily + trastuzumab (loading dose of 8 mg/kg) followed by the maintenance dose of 6 mg/kg IV q3weeks + an AI (either letrozole, anastrozole, or exemestane) of Investigator's choice PO once daily.
  2. Treatment group B: trastuzumab (loading dose of 8 mg/kg) followed by maintenance dose of 6 mg/kg IV q3weeks + an AI (either letrozole, anastrozole, or exemestane) of Investigator's choice PO once daily.
  3. Treatment group C: lapatinib 1500 mg PO once daily + an AI (either letrozole, anastrozole, or exemestane) of Investigator's choice PO once daily.

Treatment continued until disease progression, death, or unacceptable toxicities, whichever came first.

Subjects who discontinued study treatment for reasons other than disease progression were followed-up every 12 weeks until disease progression or death, until the start of post-study treatment anti-cancer therapy (including radiotherapy and surgery), withdrawal of consent, or lost to follow-up, whichever came first.

Being tested
Lapatinib, Trastuzumab, Aromatase Inhibitor
Keywords
1st line MBC, MBC, hormone receptor positive, lapatinib, trastuzumab, HER2 positive, aromatase inhibitor
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LapatinibDrug

    1000 mg by mouth once a day

  • TrastuzumabDrug

    Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks)

  • Aromatase InhibitorDrug

    Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily

  • LapatinibDrug

    1500 mg by mouth once daily

Study groups in NCT01160211
Study groupRoleWhat they receive
Treatment group AExperimentalLapatinib 1000 mg PO once daily + Trastuzumab (loading dose of 8 mg/kg) followed by the maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks) + an Aromatase Inhibitor (AI) of Investigator's choice PO once daily.
Receives: Drug: Lapatinib; Drug: Trastuzumab; Drug: Aromatase Inhibitor
Treatment group BActive comparatorTrastuzumab (loading dose of 8 mg/kg) followed by maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks) + an Aromatase Inhibitor (AI) of Investigator's choice PO once daily.
Receives: Drug: Trastuzumab; Drug: Aromatase Inhibitor
Treatment Group CActive comparatorLapatinib 1500 mg PO once daily + an Aromatase Inhibitor (AI) of Investigator's choice PO once daily.
Receives: Drug: Aromatase Inhibitor; Drug: Lapatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Events in Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs. Trastuzumab + Aromatase Inhibitor (AI)

    The Number of Participants with Progression free survival (PFS) events in the Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) arm vs. Trastuzumab + Aromatase Inhibitor (AI) arm was based on assessments by the Investigator.

    Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 5 years

  2. Median Kaplan Meier Estimates for PFS in Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs. Trastuzumab + Aromatase Inhibitor (AI)

    Progression free survival (PFS) was defined as the interval of time between the date of randomization and the earliest date of disease progression (with radiological evidence) or death from any cause, or to the date of censor. Disease progression was based on assessments by the Investigator.

    Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 5 years

Secondary outcomes (7)

  1. Progression Free Survival (PFS)

    Progression free survival (PFS) was defined as the interval of time between the date of randomization and the earliest date of disease progression (with radiological evidence) or death from any cause, or to the date of censor. Disease progression was based on assessments by the Investigator.

    Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 11 years

  2. Overall Survival (OS)

    The Number of Participants with Overall Survival (OS) events was based on assessments by the Investigator.

    Measured: From date of randomization until date of death from any cause, assessed up approximately 11 years

  3. Overall Response Rate (ORR)

    Overall Response Rate (ORR) was defined as the proportion of participants achieving either a Complete Response (CR) or Partial Response (PR). The ORR was calculated from the Investigator's assessment of response based on RECIST 1.1. Subjects with an unknown or missing response were treated as non-responders; i.e. they were included in the denominator when calculating the percentages. Subjects who do not have measurable disease contributed to the Response Rate based analyses, for the evaluation of CR, SD and PD.

    Measured: Up approximately 11 years

  4. Clinical Benefit Rate (CBR)

    Clinical Benefit Rate (CBR) was defined as the percentage of patients with evidence of Complete Response (CR), Partial Response (PR), or maintaining Stable Disease (SD) for at least 6 months while on study, according to the investigator assessment of response per RECIST 1.1 criteria.

    Measured: Up approximately 11 years

  5. Time to Response

    Time to Response (TTR) was defined as the time from randomization to the earliest date of Complete Response (CR) or Partial Response (PR)

    Measured: From date of randomization until the earliest date of Complete Response (CR) or Partial Response (PR), assessed up approximately 11 years

  6. Duration of Response (DoR)

    Duration of Response (DOR) was defined as the duration between the date of first documented Complete Response (CR) or Partial Response (PR) and the date of first documented sign of Progressive Disease or Death, or to the date of censor.

    Measured: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up approximately 11 years

  7. Mean Change in the Quality of Life (QoL) Status Relative to Baseline FACT-B Overall and Subscale Scores at Last On Treatment Assessment

    Quality of life was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. It is a 37-item (27 general questions and 10 breast cancer specific questions) self-reporting instrument consisting of 5 dimensions: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The followings were the score ranges for each self-reporting subscale: • PWB : 0-28 • SWB : 0-28 • EWB : 0-24 • FWB : 0-28 • BCS : 0-40 FACT-B Total Outcome Index (TOI) = PWB + FWB + BCS (range:0 - 96) FACT-B Total Score = PWB + SWB + EWB + FWB + BCS (range:0-148) FACT-G Total Score = PWB + SWB + EWB + FWB (range:0-108). For all the FACIT scales and symptom indices, the higher the score the better QoL

    Measured: Day 1 (pre-dose), up approximately 11 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2010 (estimated)
  2. Study start5 May 2011
  3. Primary completion11 Mar 2016
  4. Study completion6 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01160211
Sponsor's protocol ID
114299
Other IDs
2010-019577-16, CLAP016A2307
Status last verified
Mar 2025
First submitted
1 Jul 2010
Last updated
7 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. doi: 10.1200/JCO.2017.74.7824. Epub 2017 Dec 15.

    PubMed 29244528

  • Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. doi: 10.1200/JCO.20.01894. Epub 2020 Aug 21.

    PubMed 32822287

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lapatinib, Trastuzumab and Aromatase Inhibitor in people with Neoplasms, Breast, run by Novartis Pharmaceuticals at 110 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in Argentina, Brazil, Hungary, Japan, Russia and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Events in Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs. Trastuzumab + Aromatase Inhibitor (AI) (time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01160211, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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