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New combo therapy for seniors with aggressive breast cancer shows promise in early trial

NCT ID NCT01273610

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing how well older adults (60+) with advanced HER2+ breast cancer tolerate a combination of two targeted drugs: lapatinib and trastuzumab. The study enrolled 40 participants and focuses on side effects, especially heart-related issues and severe toxicities. The goal is to see if this drug pair is safe enough for this age group, who are often underrepresented in cancer trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lapatinib (Tykerb) and trastuzumab (Herceptin)
What this could lead to
If successful, this could show that combining these two targeted drugs is safe and tolerable for older adults with advanced HER2+ breast cancer, offering a treatment option for this age group.
What could go wrong
This is a small, early-phase trial focused on safety, not on proving the combination works. Side effects like heart problems or severe toxicities are possible, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Apr 2011

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Locally advanced or metastatic Her2/Neu positive breast cancer (defined as immunohistochemistry \[IHC\] 3+ or a fluorescence in situ hybridization \[FISH\] ratio of \>= 2.0); this may be on either a primary tumor or a metastatic site, and there is no time limit from the time the specimen was obtained; locally advanced breast cancer (LABC) includes breast cancers with advanced primary tumors, i.e., large diameter (at least 5 cm) or those with skin and/or chest wall involvement, and advanced regional lymph node involvement; it also includes a rare subgroup, inflammatory breast cancer; in the 2010 American Joint Committee on Cancer and the International Union for Cancer Control (AJCC-UICC) TNM breast cancer staging system, locally advanced breast cancer (LABC) includes patients with stage III disease; this comprises: * Advanced primary tumors (tumors \> 5 cm in greatest dimension \[T3\]; direct extension to the chest wall and/or to the skin \[T4\]: ulceration, skin nodules, and/or edema (including peau d'orange) confined to the same breast, inflammatory breast cancer \[IBC, T4d\]) * Advanced regional lymph nodes (ipsilateral level I, II axillary lymph nodes that are clinically fixed or matted or clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases \[N2\], ipsilateral infraclavicular \[level III axillary\] lymph nodes, ipsilateral internal mammary lymph node\[s\] with axillary lymph nodes, or ipsilateral supraclavicular lymph nodes \[N3\]) * Both measurable and non-measurable disease are allowed * Life expectancy of greater than 12 weeks * Women of child-bearing potential and sexually active men must agree to use adequate contraception prior to study entry for six months following duration of study participation * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky performance status \>= 60%) * Hemoglobin \>= 10 g/dL (after transfusion if necessary) * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin within normal institutional limits * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/aspartate aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal * Creatinine clearance \>= 30 mL/min as measured using either the Cockcroft-Gault method or 24-hour creatinine clearance * The above tests must be obtained within 14 days of study treatment * Cardiac ejection fraction \>= 50% as measured by echocardiogram or multiple gated acquisition scan (MUGA) scan * The ability to swallow and retain oral medication * Prior treatment with lapatinib or trastuzumab are allowed, provided that the agents have never been given in combination * Any number of prior cancer treatments, including investigational agents, chemotherapy, hormone therapy, or targeted therapy are allowed * All patients must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Concurrent investigational treatment, chemotherapy, or targeted therapy; prior chemotherapy, hormonal therapy, targeted therapy, and investigational agents are allowed but all toxicities grade \>= 2 must have resolved by the time of study commencement (except alopecia) * Unstable or symptomatic brain metastases (however, patients with stable or treated brain metastases who do not require steroids at doses above those permitted for control of symptoms may be enrolled) * History of allergic reactions attributed to compounds of similar chemical or biological composition to lapatinib or trastuzumab; however, patients with a history of infusion reaction to trastuzumab which was controlled with premedication on subsequent infusions without a recurring infusion reaction are eligible * Concomitant medications listed are prohibited; inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) not listed can be used with caution * Ongoing or active infection (including human immunodeficiency virus \[HIV\]) or psychiatric illness/social situations that would limit compliance with study requirements * Inability to take oral medication * Malabsorption syndrome, (prior surgical procedures affecting absorption), or inflammatory gastrointestinal (GI) disease (e.g., Crohn's, ulcerative colitis) which in the opinion of the study coordinator is likely to limit normal absorption of the drug * Current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment) * Active cardiac disease, defined as (but not limited to): * History of documented congestive heart failure (CHF) or systolic dysfunction (left ventricular ejection fraction \[LVEF\] \< 50%) * High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade atrio-ventricular \[AV\]-block, supraventricular tachycardias which are not adequately rate-controlled) * Angina pectoris requiring antianginal medications * Evidence of transmural infarction on electrocardiogram (ECG) * Clinically significant valvular heart disease * Poorly controlled hypertension (e.g. systolic \> 180 mm HG or diastolic \> 100 mm Hg) * Any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient * Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • City of Hope Antelope Valley

    Lancaster, California, 93534, United States

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Duke University Medical Center

    Durham, North Carolina, 27704, United States

  • Lineberger Comprehensive Cancer Center, University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • South Pasadena Cancer Center

    Pasadena, California, 91030, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

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