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New drug combo shows promise in early breast cancer trial

NCT ID NCT01597388

Disease control Sponsor: AstraZeneca 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new experimental drug called AZD2014 combined with the standard hormone therapy fulvestrant in 99 people with advanced ER+ breast cancer. The main goals were to check the safety of the combination and find the right dose. Researchers also looked for early signs that the treatment might help shrink tumors or slow the cancer's growth.

What this could mean

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

Active substance
AZD2014 (an experimental drug) and fulvestrant (a hormone therapy)
What this could lead to
If successful, this could lead to a new combination treatment option for people with advanced ER+ breast cancer that has stopped responding to standard hormone therapy.
What could go wrong
This is a very early Phase 1 trial with only 99 participants, focused mainly on safety and dosing. The drug may not prove effective enough to advance to larger studies, and side effects 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

99 people

The number who actually took part.

Started

May 2012

Finished

Jan 2026

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

18 to 100 years

Sex

Female participants only

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: * Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis * Aged at least 18 * At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment * Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patients must have evidence of non-child-bearing potential. Exclusion Criteria: * Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites) * Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study. * Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions. * Patients with diabetes type 1 or uncontrolled type II (HbA1c \> 8% assessed locally)

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma estrogen-receptor positive breast cancer

As listed by the trial registrant

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

Advanced/metastatic breast cancer

Contacts and locations

Locations

  • Research Site

    Sarasota, Florida, 34232, United States

  • Research Site

    Detroit, Michigan, 48201, United States

  • Research Site

    Oklahoma City, Oklahoma, 73104, United States

  • Research Site

    Greenville, South Carolina, 29605, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

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