Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for Hard-to-Treat breast cancer: Triple-Drug combo shows promise

NCT ID NCT04721977

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether adding tucatinib to standard drugs trastuzumab and capecitabine can shrink tumors in people with advanced HER2+ breast cancer who have already tried several treatments. About 66 participants will receive the three-drug combination. The main goal is to see if the tumor response rate exceeds 20%.

What this could mean

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

Active substance
tucatinib (Tukysa) combined with trastuzumab (Herceptin) and capecitabine (Xeloda)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced HER2+ breast cancer who have run out of standard therapies.
What could go wrong
This is a small, early-phase trial (66 people) with no placebo group, so results may not apply broadly. Side effects from the drug combination could be significant.

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

66 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

20 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: * Has histologically confirmed HER2+ breast carcinoma * Has received previous treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and T-DM1 with the exception of when the use of taxanes is contraindicated or judged not to be the best treatment at the investigator's discretion * Has radiographically and/or histologically confirmed disease progression on last systemic anticancer treatment * Has adequate organ function * Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP and using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 30 days after receiving the last dose of tucatinib, 80 days after receiving the last dose of trastuzumab, or 180 days after receiving the last dose of capecitabine, whichever occurs last and agrees to not donate eggs during this period * Male participants refrain from donating sperm and are either abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after receiving the last dose of tucatinib and 90 days after receiving the last dose of capecitabine, whichever occurs last * Previously treated brain metastasis is stable or progressed, provided there is no clinical indication for immediate re-treatment Exclusion Criteria: * Has been previously treated with lapatinib within 12 months of starting study treatment * Has been previously treated with neratinib, afatinib, tucatinib or capecitabine * Has a history of exposure to doxorubicin, epirubicin, mitoxantrone, idarubicin, liposomal doxorubicin * Has had treatment with any systemic anti-cancer therapy including hormonal therapy, non-central nervous system (CNS) radiation or experimental agent ≤3 weeks before first dose of study treatment * Has any toxicity related to prior cancer therapies that has not resolved with the exception of alopecia, congestive heart failure, anemia * Has clinically significant cardiopulmonary disease * Has known myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment * Has any uncontrolled viral, bacterial or fungal infection within 14 days prior to the first dose of study treatment * Is positive for Hepatitis B, Hepatitis C or has known chronic liver disease * Is known to be positive for human immunodeficiency virus (HIV) * Has evidence within 2 years of the start of study treatment of another malignancy that required systemic treatment * Has ongoing use of systemic corticosteroids for control of symptoms of brain metastases * Has any brain lesion thought to require immediate local therapy * Has known or suspected leptomeningeal disease (LMD) * Has poorly controlled generalized or complex partial seizures or manifest neurologic progression due to brain metastases

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Aichi Cancer Center Hospital ( Site 1013)

    Nagoya, Aichi-ken, 464-8681, Japan

  • Fukushima Medical University Hospital ( Site 1012)

    Fukushima, 960-1295, Japan

  • Hiroshima City Hiroshima Citizens Hospital ( Site 1024)

    Hiroshima, 730-8518, Japan

  • Hokkaido University Hospital ( Site 1022)

    Sapporo, Hokkaido, 060-8648, Japan

  • Hyogo Cancer Center ( Site 1005)

    Akashi, Hyōgo, 673-8558, Japan

  • Hyogo College of Medicine Hospital ( Site 1019)

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Juntendo University Hospital ( Site 1025)

    Tokyo, 113-0033, Japan

  • Kanagawa Cancer Center ( Site 1010)

    Yokohama, Kanagawa, 241-8515, Japan

  • Kumamoto Shinto General Hospital ( Site 1007)

    Kumamoto, 862-8655, Japan

  • Medical Corporation Nahanishikai Nahanishi Clinic ( Site 1016)

    Naha, Okinawa, 901-0154, Japan

  • Nagoya University Hospital ( Site 1021)

    Nagoya, Aichi-ken, 466-8560, Japan

  • National Cancer Center Hospital ( Site 1003)

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East ( Site 1002)

    Kashiwa, Chiba, 2778577, Japan

  • National Cheng Kung University Hospital ( Site 3000)

    Dawan, Tainan, 704, Taiwan

  • National Hospital Organization Hokkaido Cancer Center ( Site 1017)

    Sapporo, Hokkaido, 003-0804, Japan

  • National Hospital Organization Kyushu Cancer Center ( Site 1009)

    Fukuoka, 811-1395, Japan

  • National Hospital Organization Osaka National Hospital ( Site 1001)

    Osaka, 540-0006, Japan

  • National Hospital Organization Shikoku Cancer Center ( Site 1014)

    Matsuyama, Ehime, 791-0280, Japan

  • Osaka International Cancer Institute ( Site 1004)

    Osaka, 541-8567, Japan

  • Saitama Cancer Center ( Site 1018)

    Kitaadachi-gun, Saitama, 362-0806, Japan

  • Samsung Medical Center ( Site 2002)

    Seoul, 06351, South Korea

  • Seoul National University Hospital ( Site 2003)

    Seoul, 03080, South Korea

  • Severance Hospital ( Site 2001)

    Seoul, 03722, South Korea

  • Showa University Hospital ( Site 1023)

    Tokyo, 142-8666, Japan

  • Social medical corporation Hakuaikai Sagara Hospital ( Site 1008)

    Kagoshima, 892-0833, Japan

  • The Cancer Institute Hospital of JFCR ( Site 1015)

    Tokyo, 135-8550, Japan

  • Tokyo Medical University Hospital ( Site 1006)

    Tokyo, 160-0023, Japan

  • University of Tsukuba Hospital ( Site 1020)

    Tsukuba, Ibaraki, 305-8576, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.