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Freshness: 3 October 2026
Latest Breast Cancer Treatment: Approvals, Guidelines, and Research
“Latest” has to be split into four buckets: care that is already established, a recent regulator approval, a clinical trial, and early research. The rows below are US Food and Drug Administration decisions from October 2024 through May 2026. Each one applies to a defined subtype and line of therapy. None of them is a cure for breast cancer, and none of them proves a hospital in China can deliver that drug.
Applicability: read the subtype column before the drug name. A headline that skips the subtype is not a treatment claim.
Established careFDA approvalTrialEarly research
Established care is still the base
Surgery, radiation, hormone therapy for hormone-receptor-positive disease, HER2-targeted drugs for HER2-positive disease, and chemotherapy in the settings NCI describes are not “old” just because a new approval exists. New drugs are added on top of that map for narrow groups. The treatment hub is the map. This page is the change log.
Recent US approvals
| What changed | Date | Status | Who it applies to | Evidence |
|---|---|---|---|---|
| Inavolisib with palbociclib and fulvestrant | 10 Oct 2024 | FDA approved | Endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced disease after adjuvant endocrine therapy | Randomized INAVO120. FDA |
| Datopotamab deruxtecan for previously treated metastatic HR-positive, HER2-negative disease | 17 Jan 2025 | FDA approved | Unresectable or metastatic HR-positive, HER2-negative disease after endocrine therapy and chemotherapy for that setting | TROPION-Breast01. Progression-free survival improved. The FDA summary did not show a significant overall-survival difference. FDA |
| Trastuzumab deruxtecan for HR-positive HER2-low or HER2-ultralow metastatic disease | 27 Jan 2025 | FDA approved | Unresectable or metastatic HR-positive disease that is HER2-low or HER2-ultralow after endocrine therapy in the metastatic setting, with an approved test | DESTINY-Breast06. Approval rested on progression-free survival. FDA |
| Trastuzumab deruxtecan with pertuzumab | 15 Dec 2025 | FDA approved | First-line treatment of unresectable or metastatic HER2-positive disease (IHC 3+ or ISH+) | DESTINY-Breast09. FDA |
| Trastuzumab deruxtecan before or after surgery | 15 May 2026 | FDA approved | Specified HER2-positive early-stage settings: neoadjuvant use followed by a taxane, trastuzumab, and pertuzumab for stage II or III, and adjuvant use when invasive disease remains after neoadjuvant trastuzumab-taxane treatment | FDA indication text. FDA |
| Datopotamab deruxtecan for metastatic triple-negative disease | 22 May 2026 | FDA approved | Unresectable or metastatic triple-negative disease in adults who are not candidates for PD-1/PD-L1 inhibitor therapy and had not received chemotherapy for metastatic disease | TROPION-Breast02. FDA |
These rows are labelled-drug decisions. A press headline, a laboratory paper, or an unnamed “breakthrough package” is not on this list. Overall survival was not established for every row above.
What was left off on purpose
This page does not call a laboratory result, a phase 1 poster, or a hospital advertisement a breakthrough. It does not list stem-cell infusions or CAR-T as breast-cancer treatment. It does not convert a China-only marketing name into an approval. Guideline text that sits behind a subscription was not restated from memory. If a change is not in the table, this pass did not verify it.
China and access
An FDA label is a US decision. Stock, biomarkers, and international-patient acceptance in China are separate questions. New cancer treatments in China is the site page that separates labelled care from packages. Breast cancer treatment in China is the routing page for a breast-cancer file.
When a case review may help
A review can check whether a quote names a drug and a biomarker the file actually has, or whether it uses “latest” without either. It cannot enroll someone in a trial.
In this cluster
- Breast cancer treatment
- Treatment by stage
- Latest treatment (this page)
- How curable it is
- Immunotherapy
- Treatment in China
Questions people ask
Is trastuzumab deruxtecan for every breast cancer now?
No. The 2025 and 2026 FDA indications above are limited to defined HER2-positive, HER2-low, or HER2-ultralow situations, and some require prior endocrine therapy or a specific early-stage setting.
Did the January 2025 datopotamab approval show longer survival?
The FDA summary of TROPION-Breast01 reported longer progression-free survival and did not report a statistically significant overall-survival difference. That is not a cure claim.
Are these drugs the standard in China?
This page does not say that. Availability and international access have to be confirmed for a named hospital. They are not inferred from a US label.
Sources
- FDA, inavolisib. Approval dated 10 October 2024.
- FDA, datopotamab deruxtecan, HR-positive. Approval dated 17 January 2025.
- FDA, trastuzumab deruxtecan, HER2-low and ultralow. Approval dated 27 January 2025.
- FDA, trastuzumab deruxtecan with pertuzumab. Approval dated 15 December 2025.
- FDA, trastuzumab deruxtecan early-stage indications. Approval dated 15 May 2026.
- FDA, datopotamab deruxtecan, triple-negative. Approval dated 22 May 2026.
- NCI, Drugs Approved for Breast Cancer. Cross-check that these names appear on the NCI breast list.
Evidence check: 3 October 2026. US approvals are not proof that a hospital in China stocks the drug or will accept an international patient.
Separate an approval from a headline
A new drug label applies only to a defined subtype and line of therapy. ParkMega does not enroll trials or promise access in China.