Breast Cancer Drug Pipeline: 645 Assets by Phase

How many breast cancer drugs are in each phase of development?

Douglas Insights counts 111 breast cancer candidates in Phase III, 17% of the 645 assets in development; Phase II holds 143 and Phase I holds 391.

Phase I/II candidates sit in the Phase I row and Phase II/III candidates in the Phase II row, so each breast cancer asset appears in exactly one row. The 2,013 trials still recruiting or running carry 48% of the 4,202 registered trials in scope.

Which approved breast cancer medicines are still in trials?

1 medicines already on the market are still being tested in breast cancer Phase IV trials; Herceptin has the most, with 154 registered trials.

Post-approval breast cancer trials test new doses, new patient groups and head-to-head comparisons. They set the standard of care that every candidate in development will be measured against, so the paid review profiles each one.

How many breast cancer trials are recruiting patients now?

1,039 breast cancer trials are recruiting patients and 350 more have not started recruiting yet, out of 4,202 interventional trials in scope; together they make up 33% of the trial base.

Terminated, suspended and withdrawn breast cancer trials stay in the trial base so that a stalled programme is visible, but a candidate whose only trials stopped is no longer counted as in development.

Which companies lead the breast cancer pipeline?

AstraZeneca leads the breast cancer pipeline with 26 candidates; the top 5 sponsors hold 15% of the 645 assets, and 321 sponsors run at least one.

Industry sponsors lead 1,431 of the 4,202 breast cancer trials (34%); universities, hospitals and public funders lead the rest. A sponsor is credited with an asset when it is the lead sponsor on most of that asset's industry trials.

Which drug types and mechanisms dominate the breast cancer pipeline?

Mechanism and drug-type classification for the 645 breast cancer candidates is done by the research desk asset by asset, each with a cited source, and is published in the paid review together with the white-space map.

What breast cancer trial readouts are coming next?

89 breast cancer candidates in Phase II or later have a registered primary completion date in the next 12 months; the next three are below, each linked to its registry record.

Primary completion is the date a sponsor expects the last patient to finish the main measurement, so data usually follow within months. Dates marked estimated are the sponsor's own forecast on the registry and often move.

How many breast cancer readouts fall in each quarter?

142 breast cancer candidates in Phase II or later reach registered primary completion over the next eight quarters, with the most, 44, due in Q4 2026.

Each candidate is counted once, at its next readout. The paid catalyst calendar names every readout with its trial, sponsor and design, adds filings and regulatory decisions, and runs 24 months ahead.

Which countries host the most breast cancer trials?

United States hosts the most breast cancer trials, with sites in 1,970 of the 4,202 studies (47%); trials in scope run in 104 countries in all.

A multinational breast cancer trial is counted once in every country where it has a site, so the shares add up to more than 100%. Country spread shows where sponsors are building the evidence that regulators in each market will ask for.

Where are breast cancer drugs being tested?

1,970 of the 4,202 breast cancer trials (47%) have a site in the United States, 1,052 (25%) in Europe and 1,059 (25%) in China; 432 of the 645 candidates in development are tested in the US.

Each region's trials are the evidence its regulator will review: the FDA in the United States, the EMA (with the MHRA and Swissmedic) in Europe, the NMPA in China and the PMDA in Japan. A multinational breast cancer trial counts once in every region where it has a site, so the shares add up to more than 100%. A candidate tested only outside the US and Europe is often a licensing opportunity for sponsors in those markets.

What has changed in the breast cancer pipeline since the last update?

This is the first edition of the breast cancer pipeline count, dated 3 Oct 2026. The next refresh is due by 1 Jan 2027, and each refresh lists the assets that entered, advanced or dropped out.

How does Douglas Insights count the breast cancer pipeline?

Douglas Insights read 4,202 interventional trials registered on ClinicalTrials.gov for the conditions "breast cancer" and updated since 3 Oct 2021, then grouped every drug or biologic named in them into 645 unique candidates.

1. Code names, generic names and brand names of the same molecule are merged into one candidate, and every merge is reviewed by the research desk.
2. A candidate counts when it has a trial that is recruiting, running, or completed in the last 24 months, and at least one industry-sponsored trial.
3. Its phase is the highest phase among those trials; placebo, standard-of-care and comparator arms are not candidates.
4. Each figure on this page is drawn from one frozen dataset that passes ten checks before release, and the owner approves every edition.

Read the full approach on the research methodology page, or browse other Pharmaceuticals research.

Frequently asked questions about the breast cancer pipeline

Research & citation

This review was researched, written and reviewed by the Douglas Insights Research Desk under the Douglas Insights editorial standards. Material errors are logged in the corrections log. No section is sponsored.

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