APEX-Breast01

An aspect marked incomplete is a question the public commentary did not let us answer. We show it rather than hide it.

Screened window

Oct 23, 2026 → Oct 26, 2026

Cited window

Oct 23, 2026 → Oct 26, 2026

Retrieved

Oct 29, 2026

Title

A Randomized, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer

Also known as

APEX-B01

Registry

NCT06561607

Study IDs

TQB2102-III-01

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Design

Phase 3 · Interventional, randomized, parallel

Status

Active, not recruiting

Enrollment

542 estimated

Registered

2024-08-20

Start

2024-10-11 actual

Primary completion

2027-01 estimated

Primary endpoint

Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)

Interventions

2 registered

This report does not judge efficacy, estimate HCP prevalence or consensus or give treatment advice.

• –Discussion that does not name the trial may be missing from this edition.
• –Not yet captured in this edition: a remark on chemotherapy-naive patient selection, progression-free survival and interstitial lung disease with the trial intervention versus chemotherapy.
• –Some clinician views in the sources used in this report are not yet captured as evidence in this edition.
• –Some passages in the sources used in this report were not fully assessed for clinician views, so a view there may be missing from this edition.
• –18 statements in the sources reviewed for this edition are about other patients or topics, or only mention the trial, and are not counted.
• –Further source limits: discussion that describes the trial without naming it may be incomplete; some discussion that describes the trial without naming it may be missing; sources about other trials are not included.
• –The sources reviewed for this edition are a limited collection of posts and a video, not a representative sample of HCP opinion. Reposts and repeated quotations should not be counted as independent endorsements.
• –Parts of several sources were not fully assessed. Discussion using alternative wording, transcription variants or no trial name may be missing, so the report cannot establish that all relevant views or qualifications have been captured.
• –The video’s explanation of activity below the conventional HER2-positive threshold concerns possible therapeutic effects of certain ADCs, not guaranteed activity. Its diagnostic-selection rationale should not be read as an additional APEX-Breast01 efficacy result.
• –No full protocol or exact-trial results publication was available. The registry material describes planned methods and has no posted results; efficacy and safety figures in this report remain attributed accounts from commentary.
• –No exact regulatory label matching the registry’s named interventions was available. The reported Chinese application acceptance does not independently establish marketing approval, access or reimbursement.
• –Some speakers' identities or clinical roles are not established in the sources used in this report; each statement is attributed only as far as its source shows.
• –The registry’s planned enrollment of 542 and commentary reports of 543 participants are not reconciled here. Differences in reported response populations and safety summaries should likewise not be combined into a single independently verified dataset.
• –Cross-trial comparisons cannot establish that a control arm was weak, that similar medians imply equivalent efficacy, or that one ADC is safer. The report preserves those interpretations and cautions as expressed rather than adjudicating them.

How reports are built and checked: Methods.

Last checked for new commentary Oct 29, 2026. A new or changed finding gets a new version number; added evidence alone is a smaller update. No corrections.

Paste this into ChatGPT, Claude, Microsoft Copilot or your own agent. It previews this report through the free Erudio MCP server, tells you whether it answers your question, and orders it if you ask. Some agents ask you to confirm pasted instructions before acting; that is expected.

Help me decide whether to buy the Erudio report "APEX-Breast01" (NCT06561607), and buy it for me if I ask. Erudio reports cover what clinicians say in public about one clinical trial, with every verified statement linked to its source.

1. Use the free Erudio MCP server at https://mcp.erudio.com/free; it needs no sign-in. Nothing needs installing: if it is not connected in this app and you can make HTTP requests, call it directly with JSON-RPC POSTs to that URL (initialize, then tools/call), sending "Accept: application/json, text/event-stream". Call get_report_card with slug "apex-breast01-06561607". If you cannot make requests, read https://www.erudio.com/reports/apex-breast01-nct06561607.md instead.
2. In a few lines, tell me what the report covers: its findings, its verified statements and sources, its evidence window, what it leaves out, and the price of each product (offer). Then ask what I need it for, and say plainly whether this report answers it.
3. If I want it, ask for my work email and the product: the current edition, or 3, 6 or 12 months of weekly updates. Call create_order with report "NCT06561607", that product and email, then show me the quote and the checkout_url to pay by card. If you have a payment client for HTTP 402 payments and I agree, you can pay the pay_url instead. Nothing is charged until one is paid.
4. Once it is paid, call get_order with the status_url: it returns my license key. Then use the Erudio MCP server at https://mcp.erudio.com/mcp with the header "Authorization: Bearer <key>". Call read_report with report_id erudio-nct06561607 and sections ["all"], and summarize the findings for me with their sources. The full report is large (about 500 KB): save the response to a file and work from it rather than printing it. If you cannot, read sections ["narratives"] first, the executive summary and analysis.

When you tell me what clinicians said, give each view as theirs, with its source. Counts are the sources the report kept, not the share of clinicians who agree. Reports are not medical advice.
Keep the key private to my organization.

curl https://www.erudio.com/reports/apex-breast01-nct06561607.json
curl https://www.erudio.com/reports/apex-breast01-nct06561607.md

# MCP, no sign-in (https://mcp.erudio.com/free)
get_report_card({ "slug": "apex-breast01-06561607" })