The Latest Advances in Systemic Treatment of Breast Cancer: NEJM 2026 Review
In this article
What has changed since 2020? New drugs by subtype and personalized treatment
Published in The New England Journal of Medicine on 7 October 2026, the review entitled "Advances in Systemic Treatment of Breast Cancer"summarizes the rapid changes in drug treatment for breast cancer since 2020. Three forces are driving this change: targeted drugs, antibody-drug conjugates and immunotherapy. The genetic characteristics of the tumor and the individual now determine treatment selection. The goal is to intensify treatment in high-risk patients and avoid unnecessary treatment in low-risk patients.
- Hormone receptor-positive, HER2-negative: CDK4/6 inhibitors remain the mainstay of treatment. When resistance to hormone therapy develops, PI3K pathway drugs, new oral estrogen receptor degraders and antibody-drug conjugates have expanded the options.
- HER2-positive: Trastuzumab deruxtecan (T-DXd) increased median overall survival in metastatic disease from 42,7 months to 52,6 months compared with T-DM1. It is now also used in the first line and in early-stage disease. Lung inflammation (ILD) requires close monitoring.
- Triple-negative: Preoperative chemotherapy with pembrolizumab increased 5-year overall survival from %81,7 to %86,6. In metastatic disease, two antibody-drug conjugates received first-line approval in 2026.
- Individualized escalation and de-escalation: Circulating tumor DNA (ctDNA) guided a treatment change for the first time. Chemotherapy can be reduced in some HER2-positive patients. The high cost of new drugs, however, creates inequalities in access.
Why does this topic matter?
Breast cancer is the most common cancer in women. According to GLOBOCAN 2024 estimates, approximately 25 thousand women in Türkiye receive this diagnosis each year. Over the past six years, the US Food and Drug Administration (FDA) has approved dozens of new drugs or indications in breast cancer. This pace makes it difficult even for physicians to keep up; for patients, it makes the question "Is there a new treatment suitable for me?" more important than ever.
The essence of the change is this: breast cancer is not treated as a single disease. Subtypes distinguished by hormone receptor and HER2 status, and within them, inherited or tumor-specific genetic changes such as PIK3CA, ESR1 and BRCA, determine treatment. We discussed the role of chemotherapy in this picture and who does not need it in our article on chemotherapy .
What are the new treatments for breast cancer?
The prominent new treatments in breast cancer since 2020 include antibody-drug conjugates (trastuzumab deruxtecan, sacituzumab govitecan, datopotamab deruxtecan), PI3K and AKT pathway drugs (inavolisib, capivasertib), oral estrogen receptor degraders (elacestrant, imlunestrant, vepdegestrant, camizestrant) and immunotherapy in triple-negative disease. The tumor's subtype and genetic tests determine which is appropriate.
Notable FDA approvals over six years
Figure 1 · Prominent treatments since 2020 by subtype
Simplified map; each drug's use depends on stage, prior treatments and tests.
- Direct comparison: In each chart, the colored bar shows the new treatment and the gray bar immediately below it shows the control arm in the same randomized trial. The difference between these two is reliable.
- Indirect comparison: Bars from different trials stand side by side, but can only be compared indirectly. Patient populations, prior treatments, control arms and follow-up durations differ; these charts do not answer the question "which drug is better."
- Red bars: Show side effects requiring close monitoring, such as lung inflammation (ILD).
What has changed in hormone receptor-positive, HER2-negative breast cancer?
In this subtype, which constitutes the largest group of breast cancers, CDK4/6 inhibitors with hormone therapy remain the mainstay of treatment. In metastatic disease, ribociclib (MONALEESA-2) prolonged median overall survival from 51,4 months to 63,9 months; the overall survival difference with palbociclib was not statistically significant. In early-stage disease, the 7-year results for abemaciclib showed increases in invasive disease-free survival from %70,9 to %77,4 and overall survival from %85,0 to %86,8 (HR 0,84). In the NATALEE trial, ribociclib increased 5-year invasive disease-free survival from %81,0 to %85,5; overall survival data have not yet matured. We described the development of these drugs in our article on CDK4/6 inhibitors .
CDK4/6 inhibitors in early-stage HR+/HER2- disease
Percentage. Colored bar: CDK4/6 inhibitor + hormone therapy; gray bar: hormone therapy alone.
Disease-free: invasive disease-free survival. In monarchE, the absolute difference was 6,5 points in disease-free survival and 1,8 points in overall survival. Overall survival data in NATALEE have not yet matured. monarchE included higher-risk (node-positive) patients. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Treatment approach in early-stage HR+/HER2- disease
Figure 2 · General approach to early-stage HR+/HER2- breast cancer
Simplified diagram; the final decision is made by the tumor board and with the patient.
The main innovation comes after resistance to hormone therapy develops. Genetic changes tested in the tumor or blood now determine drug selection:
| Drug (trial) | For whom? | Result |
|---|---|---|
| Inavolisib + palbociclib + fulvestrant (INAVO120) | PIK3CA-mutated, early resistance to hormone therapy | Median overall survival from 27,0 to 34,0 months (HR 0,67) |
| Capivasertib + fulvestrant (CAPItello-291) | After CDK4/6; approved for those with AKT pathway alterations | Progression-free survival from 3,1 to 7,3 months (HR 0,50); overall survival difference not significant in the final analysis |
| Elacestrant (EMERALD) | ESR1-mutated | Progression-free survival from 1,9 to 3,8 months (HR 0,55) |
| Imlunestrant ± abemaciclib (EMBER-3) | ESR1-mutated | Alone, from 3,8 to 5,5 months; with abemaciclib, from 5,5 to 9,4 months |
| Vepdegestrant (VERITAC-2) | ESR1-mutated | Progression-free survival from 2,1 to 5,0 months (HR 0,57) |
| T-DXd (DESTINY-Breast04 and 06) | HER2-low or ultralow | Overall survival in the HR+ group from 17,5 to 23,9 months (DB-04); progression-free survival before chemotherapy from 8,1 to 13,2 months (DB-06) |
| Sacituzumab govitecan (TROPiCS-02) | Heavily pretreated patients | Overall survival from 11,2 to 14,4 months (HR 0,79) |
| Datopotamab deruxtecan (TROPION-Breast01) | After hormone therapy and chemotherapy | Progression-free survival from 4,9 to 6,9 months; no overall survival difference |
Progression-free survival after resistance to hormone therapy
Median progression-free survival (months). Colored bar: new treatment; gray bar: control (usually fulvestrant or standard hormone therapy).
SERENA-6 was conducted in the first line, while the others were mostly after CDK4/6 inhibitors; the durations should therefore not be compared with one another. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Overall survival in metastatic HR+/HER2- disease
Median overall survival (months). Colored bar: new treatment; gray bar: control arm in the same trial.
There was no overall survival difference in TROPION-Breast01 (HR 1,01). The difference in the PALOMA-2 trial of palbociclib was also not significant (53,9 versus 51,2 months). Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
The striking point in the table is that most drugs have been shown to delay disease progression, but only some have been shown to prolong overall survival. The benefit of oral estrogen receptor degraders is seen mainly in patients with ESR1 mutations. We discussed PI3K pathway drugs in 2026 PI3K inhibitors, and imlunestrant in this article .
Treatment algorithm for metastatic HR+/HER2- disease
Figure 3 · Treatment sequencing in metastatic HR+/HER2- breast cancer
Simplified diagram; drug selection depends on prior treatments, tests and access in the country.
Side effects of HR+/HER2- treatments
New drugs differ in their side effect profiles as well as their efficacy. Reduced blood counts with CDK4/6 inhibitors, diarrhea with abemaciclib, elevated blood sugar and mouth sores with PI3K pathway drugs, and nausea, lung inflammation and mouth sores with antibody-drug conjugates are prominent. Drug selection should therefore take into account patient characteristics such as diabetes and liver and lung status.
Selected side effects of HR+/HER2- treatments
Percentage. Colored bar: new drug; gray bar: control arm in the same trial.
Neutropenia due to CDK4/6 inhibitors is usually asymptomatic; febrile neutropenia with palbociclib occurs in %1,8. Abemaciclib-related diarrhea usually appears in the first weeks and is managed with antidiarrheal medication. QT prolongation with ribociclib (grade 3-4: %4,5) is monitored by ECG. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Safety of antibody-drug conjugates in HR+ disease
Percentage. Colored bar: ADC; gray bar: chemotherapy.
Red bars show ILD; deaths due to ILD occurred in %0,8 in DESTINY-Breast04 and %0,7 in DESTINY-Breast06. Ocular adverse events occurred in %40 in the datopotamab deruxtecan arm (grade 3: %0,8). Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
What has changed in HER2-positive breast cancer?
Trastuzumab deruxtecan (T-DXd) is at the center of change in this subtype. T-DXd carries a chemotherapy molecule attached to an antibody that recognizes HER2 and is an antibody-drug conjugate. It first proved itself in the second line in metastatic disease and is now moving to earlier lines:
| Trial | Comparison | Result | Lung inflammation (ILD) |
|---|---|---|---|
| DESTINY-Breast03 (metastatic, 2. line) | T-DXd versus T-DM1 | Median overall survival from 42,7 to 52,6 months (HR 0,73); progression-free survival from 7,2 to 29,0 months | %16,7 versus %3,4 |
| DESTINY-Breast09 (metastatic, 1. line) | T-DXd + pertuzumab versus standard THP | Progression-free survival from 26,9 to 40,7 months (HR 0,56); overall survival data have not matured | %12,1 versus %1,0 |
| DESTINY-Breast05 (residual tumor after surgery) | T-DXd versus T-DM1 | 3-year invasive disease-free survival from %83,7 to %92,4 (HR 0,47) | %9,6 versus %1,6 |
| DESTINY-Breast11 (before surgery) | T-DXd→THP versus anthracycline-containing ddAC→THP | Pathological complete response from %56,3 to %67,3; grade 3 or higher adverse events from %55,8 to %37,5 | %4,4 versus %5,1 |
Survival in metastatic HER2+ disease
Median duration (months). Colored bar: new treatment; gray bar: control arm in the same trial.
Overall survival data in DESTINY-Breast09 have not yet matured. HER2CLIMB also included heavily pretreated patients and patients with brain metastases. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Results in early-stage HER2+ disease
Percentage. Colored bar: new treatment; gray bar: control arm in the same trial.
Disease-free: invasive disease-free survival. The comparator arm in DESTINY-Breast05 is T-DM1; thus, T-DXd also surpassed the new standard established by KATHERINE. Survival data are not yet available in DESTINY-Breast11. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Two deaths due to ILD were reported in each of DESTINY-Breast09 and 05. Shortness of breath and cough should therefore be reported early by every patient receiving T-DXd; we explained ILD risk in detail in this article . Other developments: tucatinib is also effective in patients with brain metastases (HER2CLIMB) and prolonged progression-free survival from 16,3 to 24,9 months in first-line maintenance treatment (HER2CLIMB-05). In KATHERINE, among patients with residual tumor, T-DM1 increased 7-year overall survival from %84,4 to %89,1.
Side effects of HER2+ treatments
Selected side effects of HER2+ treatments
Percentage. Colored bar: new treatment; gray bar: control arm in the same trial.
Two deaths due to ILD were reported in each of DESTINY-Breast09 and 05. Treatment discontinuation due to side effects occurred in %17,9 versus %12,7 in DESTINY-Breast05 and %18,0 versus %2,1 in KATHERINE. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Treatment approach in early-stage HER2+ disease
Figure 4 · General approach to early-stage HER2+ breast cancer
Simplified diagram; tumor size and lymph node status determine the pathway.
Treatment sequencing in metastatic HER2+ disease
- First line: Taxane + trastuzumab + pertuzumab (THP) or T-DXd + pertuzumab (DESTINY-Breast09; FDA December 2025). Adding tucatinib in maintenance after first-line treatment prolonged progression-free survival (HER2CLIMB-05).
- Second line: T-DXd if not received in the first line (DESTINY-Breast03). The best sequence for patients receiving T-DXd in the first line remains uncertain.
- Later lines: Tucatinib + trastuzumab + capecitabine (particularly for brain metastases), T-DM1 and other HER2-targeted treatments.
What has changed in triple-negative breast cancer?
| Trial | For whom? | Result |
|---|---|---|
| KEYNOTE-522: pembrolizumab + chemotherapy | High-risk early-stage | 5-year event-free survival from %72,2 to %81,2; 5-year overall survival from %81,7 to %86,6 (HR 0,66) |
| KEYNOTE-355: pembrolizumab + chemotherapy | Metastatic, PD-L1 CPS ≥10 | Median overall survival from 16,1 to 23,0 months (HR 0,73) |
| ASCENT-04: sacituzumab govitecan + pembrolizumab | Metastatic, 1. line, PD-L1 CPS ≥10 | Progression-free survival from 7,8 to 11,2 months (HR 0,65) |
| ASCENT-03: sacituzumab govitecan | Metastatic, 1. line, unsuitable for immunotherapy | Progression-free survival from 6,9 to 9,7 months (HR 0,62); overall survival data have not matured |
| TROPION-Breast02: datopotamab deruxtecan | Metastatic, 1. line, unsuitable for immunotherapy | Progression-free survival from 5,6 to 10,8 months; overall survival from 18,7 to 23,7 months (HR 0,79) |
| OlympiA: olaparib | High-risk early-stage with inherited BRCA mutation (all HER2-negative patients) | 6-year overall survival from %83,2 to %87,5 (HR 0,72) |
Survival in triple-negative disease
Early-stage, percentage. Colored bar: pembrolizumab + chemotherapy; gray bar: placebo + chemotherapy.
In early-stage disease, the absolute gain is 4,9 points in overall survival and 9 points in event-free survival. In patients with residual tumor despite preoperative treatment, capecitabine (CREATE-X triple-negative subgroup) increased overall survival from %70,3 to %78,8.
Survival in metastatic triple-negative disease
Median duration (months). Colored bar: new treatment; gray bar: chemotherapy or chemotherapy + placebo.
Overall survival data in ASCENT-04 and ASCENT-03 have not yet matured. ASCENT was conducted in patients who had received at least two prior treatments. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Treatment approach in early-stage triple-negative disease
Figure 5 · General approach to early-stage triple-negative breast cancer
Simplified diagram; high risk is defined by tumor size and lymph node status.
Treatment sequencing in metastatic triple-negative disease
- What to assess at the outset: PD-L1 (CPS), inherited BRCA and HER2-low status.
- PD-L1 CPS ≥10: Pembrolizumab + chemotherapy or sacituzumab govitecan + pembrolizumab (ASCENT-04).
- Those unsuitable for immunotherapy: Sacituzumab govitecan (ASCENT-03) or datopotamab deruxtecan (TROPION-Breast02); both received FDA approval in 2026.
- Inherited BRCA mutation: A PARP inhibitor is an option.
- Later lines: Sacituzumab govitecan if not previously received, T-DXd if HER2-low, and chemotherapy.
Side effects of triple-negative treatments and BRCA
Selected side effects of triple-negative treatments
Percentage. Colored bar: new treatment; gray bar: control arm in the same trial.
In KEYNOTE-522, grade 3 or higher adverse events were similar in the two arms (%77,1 versus %73,3); adrenal insufficiency occurred in %2,6 in the pembrolizumab arm, and some immune-related side effects require permanent hormone therapy. In TROPION-Breast02, mouth sores occurred in %57 (grade 3: %8) and ILD in %3. Bars from different trials can only be compared indirectly; patient populations, prior treatments and follow-up durations differ.
Olaparib for inherited BRCA mutation (OlympiA)
6-year overall survival and selected side effect (percentage). Colored bar: olaparib; gray bar: placebo.
Absolute gain approximately 4,3 points (HR 0,72). Grade 3 or higher anemia in the olaparib arm: %8,7. The trial included high-risk early-stage HER2-negative patients (triple-negative and HR+).
For immune-related side effects of immunotherapy and their management, you can consult our immunotherapy side effects article; we described the approach to small early-stage tumors in our stage 1 triple-negative breast cancer article. In triple-negative disease, for patients with residual tumor despite preoperative treatment, postoperative capecitabine is also an option; in the triple-negative subgroup of CREATE-X, overall survival increased from %70,3 to %78,8.
Escalate or de-escalate treatment? ctDNA and individualized decisions
One of the review's main messages is that treatment is now adjusted according to risk. Treatment is intensified in high-risk patients: for example, changing the drug for residual tumor that does not respond to preoperative treatment (T-DM1, T-DXd, capecitabine, olaparib) or adding a CDK4/6 inhibitor in early-stage disease. In low-risk patients, treatment is reduced:
- Small HER2-positive tumors: In small tumors without lymph node involvement, paclitaxel and trastuzumab alone (APT trial) resulted in 10-year invasive disease-free survival of %91,3 and overall survival of %94,3.
- Chemotherapy-free approach: In the phase 2 PHERGain trial, some HER2-positive patients showing an early response on PET were treated without chemotherapy; 3-year invasive disease-free survival was %94,8.
- Genomic testing: In a substantial proportion of hormone receptor-positive, HER2-negative patients, chemotherapy can be avoided.
Figure 6 · Early drug switching guided by circulating tumor DNA (SERENA-6)
Treatment is changed when a resistance mutation is detected in blood, before disease progression on imaging.
In SERENA-6, this approach prolonged progression-free survival from 9,2 to 16,0 months (HR 0,44). Despite the advisory committee's vote against it, the FDA granted accelerated approval to camizestrant in September 2026; the overall survival difference is not yet significant (HR 0,87). Treating according to ctDNA in early-stage disease is not yet proven: in ZEST, ctDNA was detected in only %7,7 of the 1.901 patients tested.
- New treatments covered by SGK (conditional): Palbociclib and ribociclib have also been covered for premenopausal women with metastatic disease since October 2023. Pembrolizumab has been covered since July 2025 for high-risk early-stage triple-negative disease and metastatic disease with PD-L1 CPS ≥10. Sacituzumab govitecan is covered for metastatic triple-negative disease after at least two lines of treatment, and olaparib for patients with inherited BRCA mutations under certain conditions. The SUT amendment published in October 2026 also included postoperative use of T-DM1 for residual tumor in reimbursement coverage.
- Licensed but not covered: Abemaciclib, trastuzumab deruxtecan (Enhertu), alpelisib, capivasertib, elacestrant and tucatinib are licensed in Türkiye but are not on the SGK reimbursement list (licensed but unreimbursed drugs). Early-stage use of ribociclib is also not covered. We explained Enhertu's status in this article .
- Not yet available: We could not find licensing information in Türkiye for inavolisib, imlunestrant, vepdegestrant, camizestrant, gedatolisib and datopotamab deruxtecan, which received FDA approvals in 2025-2026.
- Genomic tests: We found no regulation regarding SGK coverage for tests such as the 21-gene test.
- Note: Reimbursement conditions change frequently; when planning treatment, they should be confirmed against the current SUT text and with the hospital pharmacy.
Frequently asked questions
- What are the newest treatments for breast cancer?
- Antibody-drug conjugates (trastuzumab deruxtecan, sacituzumab govitecan, datopotamab deruxtecan), PI3K and AKT pathway drugs, new oral estrogen receptor degraders and immunotherapy in triple-negative disease are the prominent treatments of recent years. Which is appropriate is determined by the tumor's subtype and genetic tests.
- Have targeted drugs replaced chemotherapy?
- Not entirely. Antibody-drug conjugates also carry a chemotherapy molecule, but deliver it directly to the tumor cell through an antibody. In some situations they are more effective and better tolerated than conventional chemotherapy; nevertheless, they have their own side effects, such as the risk of lung inflammation.
- Which genetic tests should be performed in breast cancer?
- Hormone receptor and HER2 status are assessed in the tumor in every patient. In metastatic hormone receptor-positive disease, PIK3CA and ESR1 alterations are sought in the tumor or blood. Inherited BRCA testing is recommended for suitable patients; the result concerns both treatment and family members.
- What is the ctDNA test, and should everyone have it?
- ctDNA is tumor-derived DNA circulating in blood. It can be used in metastatic hormone receptor-positive disease to detect an ESR1 mutation early and change the drug. Making treatment decisions according to ctDNA in early-stage disease is not yet proven; it is not routinely recommended for everyone.
Glossary
- CDK4/6 inhibitor
- A group of oral drugs that suppress enzymes responsible for cell division and are given with hormone therapy (palbociclib, ribociclib, abemaciclib).
- Antibody-drug conjugate (ADC)
- A drug consisting of a chemotherapy molecule attached to an antibody that recognizes the tumor cell.
- HER2-low
- A tumor with a HER2 test result of 1+ or 2+ (ISH-negative); it used to be considered HER2-negative.
- ESR1 mutation
- An alteration in the estrogen receptor gene that usually develops during aromatase inhibitor treatment and causes resistance to hormone therapy.
- Oral SERD
- An oral drug that binds to the estrogen receptor and directs it toward degradation.
- ctDNA
- DNA fragments circulating in blood that originate from tumor cells.
- Pathological complete response
- No viable tumor remaining in the tissue removed by surgery after preoperative treatment.
- ILD
- Interstitial lung disease; lung inflammation that may occur with some drugs such as T-DXd.
DROZDOGAN Academy Commentary
Over six years, breast cancer treatment has become a map based on subtype and genetic testing. Getting the drug to the patient is as important as reading the map.
⚡ Why it matters
A substantial proportion of new drugs are effective only in patients with a specific genetic alteration. Without the right test, a patient may remain unaware of the treatment best suited to them.
✅ Strengths
Large randomized phase 3 trials underpin the changes. In early-stage disease, pembrolizumab, T-DM1, olaparib and abemaciclib have shown overall survival benefits beyond reducing recurrence. T-DXd prolonged overall survival in metastatic HER2-positive disease.
⚠️ Limitations
Many new approvals are based on progression-free survival; with drugs such as capivasertib, datopotamab deruxtecan (in the HR+ group) and camizestrant, an overall survival benefit has not been demonstrated or is not yet known. Some approvals are accelerated approvals. Side effects such as ILD and the cost of long-term treatment should be taken into account.
🩺 In practice
The subtype should be correctly identified in every patient; PIK3CA and ESR1 testing should be performed in metastatic hormone receptor-positive disease, and inherited BRCA testing in suitable patients. Treatment sequence, prior treatments and patient preferences should be considered together by the tumor board.
❓ Open questions
The best sequence of ADCs, ctDNA use in early-stage disease, whether immunotherapy can be shortened after pathological complete response (OptimICE-pCR), and equal access to new drugs are questions awaiting answers.
Conclusion: The period after 2020 in breast cancer represents a transition from "the same treatment for everyone" to "the right drug for the right patient at the right time." For this transition to benefit patients, the right tests must be performed and access to proven treatments must be ensured.
- This article was prepared in October 2026.
- Only the abstract of the NEJM review was accessed; trial data in this article were obtained from primary publications, FDA announcements and reliable secondary sources, rather than from the review. The review's author, Dr. Hurvitz, is among the authors of some trials (for example, ASCENT, VIKTORIA-1).
- The 7-year KEYNOTE-522 data, the updated SERENA-6 survival analysis and the 6-year OlympiA data are based on conference presentations. Overall survival data in DESTINY-Breast09 and ASCENT-03 have not matured.
- Licensing and reimbursement information in Türkiye was compiled from secondary sources reporting SUT amendments; it should be confirmed against official texts.
- Each trial's own arms are compared in the charts; comparisons between different trials are indirect. Side effect rates are defined differently across trials as "any grade," "grade 3 or higher" or "drug-related," as specified in each row of the chart. Some side effect data were obtained from conference abstracts, product information and reliable secondary sources rather than the primary article.
- The diagrams were derived from verified statements in the text; they contain no new data. The Academy commentary belong to us.
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