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Breast Cancer Clinical Trials: Who May Qualify and What to Check

Breast cancer clinical trials test a new treatment, combination, sequence, or strategy in a defined group of people. Eligibility can depend on stage, whether the cancer has spread, ER, PR, and HER2 status, specific mutations, earlier treatment, organ function, performance status, where the trial is open, and that trial’s own rules. A matching diagnosis does not by itself mean someone can join. Screening is not enrollment.

The study protocol decides. This page does not enroll anyone, accept anyone, or treat an experimental option as better care.

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Not only metastatic diseaseSubtype is not eligibilityScreening is not enrollment

What are clinical trials for breast cancer?

A clinical trial is a research study with rules written before anyone joins. In breast cancer, the study may test a new drug, a new combination, a new sequence, a biomarker-selected therapy, a new use of an already approved drug, a cell therapy, a vaccine, a radiation strategy, a surgical strategy, or a supportive-care intervention. The National Cancer Institute describes trials as research studies that test ways to find, prevent, and treat cancer, and ways to manage symptoms.

Experimental does not mean better. A study exists because the answer is still open. The result can favor the new approach, show no added benefit, or find harm. An approval on the latest breast cancer treatment page is a different bucket from an open trial.

Phase I

Phase I looks first at safety and dose, usually in a small group. It is not designed to prove that the treatment helps people live longer.

Phase II

Phase II asks whether the approach has an anticancer effect and what the side effects look like in a larger, still selected, group.

Phase III

Phase III compares the study approach with usual care, or with another active treatment, in a larger group. Many of these studies assign people by chance. A phase III record can still be the wrong study for a particular subtype or line of therapy.

Phase IV

Phase IV happens after a drug is approved. It collects more safety information and watches how the treatment is used in wider practice. Approval for one breast-cancer use can sit beside a phase IV question, or beside a new trial, for a different use. This page does not list a phase IV study, because no phase IV record was opened and status-checked for the examples below.

Who qualifies for a breast cancer clinical trial?

The trial team qualifies someone, using that protocol. This table is the list of checks. It is not a decision about any person.

Check	What the protocol may require
Disease setting	Early breast cancer, locally advanced disease, or metastatic disease. Each protocol defines the setting in its own words.
Subtype	Hormone-receptor-positive and HER2-negative, HER2-positive, or triple-negative. These groups do not share one trial list.
Biomarkers and molecular features	ER, PR, and HER2 are the usual start. Some protocols also require a mutation such as PIK3CA, a genomic risk assay, or a rule about PD-1 or PD-L1 treatment. HER2-low is a different category from HER2-positive.
Prior treatment	Some studies require a prior drug class, such as a CDK4/6 inhibitor. Others exclude that class, or exclude prior chemotherapy for metastatic disease. Progression after treatment is not a universal ticket in.
Current disease status	Examples include measurable disease, residual invasive disease after neoadjuvant therapy, or previously untreated metastatic disease. The registry states which one.
Organ function and performance status	Blood counts, liver and kidney tests, heart function, and a performance score such as ECOG 0 or 1 appear in many breast-cancer protocols. The cutoff belongs to that trial.
Location and travel	A site has to be open to screening. A country name on a record is not a visa, a hospital bed, or acceptance of a foreign patient.
Trial-specific criteria	Washout times, brain metastases, caps on prior anthracycline dose, and lab cutoffs live in the inclusion and exclusion text. That text outranks a summary on this page.

This is a map of questions for a records review. It is not medical advice and it does not say that anyone qualifies.

Are clinical trials only for metastatic breast cancer?

No. Metastatic studies are common, and early-stage studies are common too. On 3 October 2026, ClinicalTrials.gov still listed recruiting phase 3 studies for stage II–III hormone-receptor-positive disease and for early triple-negative disease after surgery. A metastatic diagnosis is not required to ask the question, and it is not enough to join a metastatic study.

Usual care for early and metastatic disease is explained on the treatment and stage pages. Those pages are the treatment map. This page is the trial check.

How do I find a clinical trial for my breast cancer subtype?

Start with the pathology report, then use a registry. On ClinicalTrials.gov, search breast cancer, add the subtype words, set the status filter to recruiting, and open the eligibility text. A hospital brochure, a news headline, and a package quote are not a registry.

There is no separate ParkMega URL for HER2-positive trials, triple-negative trials, hormone-receptor-positive trials, metastatic trials, or China-only trials. Those questions are sections of this page. New cancer treatments in China is the general page that separates labelled care from trial marketing. It is not a breast-cancer trial list.

Examples checked on 3 October 2026

ClinicalTrials.gov is the source for every status below. A search for recruiting breast-cancer studies with a China location returned 654 records that day. Six records were read in full. This is not a directory, not an enrollment list, and not a statement that the study treatment is better.

NCT06926868, IZABRIGHT-Breast01

Phase: Phase 2/3. Randomized, open-label.
Population: Previously untreated locally advanced, recurrent inoperable, or metastatic triple-negative breast cancer, or ER-low HER2-negative disease, in people who are not candidates for anti-PD-1 or anti-PD-L1 therapy.
Intervention: Izalontamab brengitecan (iza-bren), an EGFR/HER3 antibody-drug conjugate, compared with physician’s choice of chemotherapy.
Recruiting status: Recruiting. Status verified 2026-07. Record updated 2026-08-10.
Countries / sites: Recruiting locations included China, the United States, and other countries. China sites marked recruiting included Beijing Cancer Hospital and Cancer Hospital, Chinese Academy of Medical Sciences. The full site list is on the registry.
Last verified: 3 October 2026, from the ClinicalTrials.gov study record.
What it does not mean: A triple-negative diagnosis does not create eligibility. Randomization does not promise the antibody-drug conjugate. A recruiting line at a Beijing hospital is not a ParkMega referral and does not say a foreign patient will be accepted.

NCT06393374, MK-2870-012

Phase: Phase 3. Randomized, open-label, adjuvant.
Population: Triple-negative breast cancer treated with neoadjuvant therapy, with residual disease at surgery rather than a pathological complete response.
Intervention: Sacituzumab tirumotecan plus pembrolizumab, compared with physician’s choice, described in the record as pembrolizumab or pembrolizumab plus capecitabine.
Recruiting status: Recruiting. Status verified 2026-09.
Countries / sites: Recruiting locations included the United States, Japan, the United Kingdom, and other countries. The 3 October 2026 record listed 311 locations and no China site.
Last verified: 3 October 2026, from the ClinicalTrials.gov study record.
What it does not mean: Residual disease after surgery does not by itself qualify someone. Pembrolizumab already has approved breast-cancer uses. This combination, in this residual-disease comparison, is still a trial. It is not the standard adjuvant plan for every triple-negative case.

NCT06058377

Phase: Phase 3.
Population: Stage II or III hormone-receptor-positive, HER2-negative breast cancer with a MammaPrint High 2 risk result. HER2-positive disease is excluded. The record says HER2-low cases that will not receive HER2-targeted therapy can be considered.
Intervention: Neoadjuvant durvalumab added to paclitaxel, doxorubicin, and cyclophosphamide, compared with that chemotherapy alone.
Recruiting status: Recruiting. Status verified 2026-08. Record updated 2026-10-01.
Countries / sites: Recruiting locations were in the United States and Puerto Rico. No China site was listed.
Last verified: 3 October 2026, from the ClinicalTrials.gov study record.
What it does not mean: Immunotherapy is not established care for hormone-receptor-positive breast cancer because this study is open. The immunotherapy page is where that limit is explained. A high-risk assay result is not enrollment.

NCT06982521

Phase: Phase 3. Randomized, open-label.
Population: Locally advanced or metastatic hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation, after recurrence or progression on or after a CDK4/6 inhibitor.
Intervention: Zovegalisib (RLY-2608) plus fulvestrant, compared with capivasertib plus fulvestrant.
Recruiting status: Recruiting. Status verified 2026-07. Record updated 2026-09-03.
Countries / sites: Recruiting locations included the United States, the United Kingdom, Hong Kong, and other countries. The record did not list a mainland China site.
Last verified: 3 October 2026, from the ClinicalTrials.gov study record.
What it does not mean: A PIK3CA result is not eligibility. Prior CDK4/6 treatment is an entry condition here, and it is an exclusion in other studies. One arm uses a drug class that already has approved uses. That does not make the trial itself standard care, and it does not mean every participant receives zovegalisib.

NCT07294508

Phase: Phase 2/3. Randomized, open-label.
Population: HER2-positive recurrent or metastatic breast cancer, defined in the record as IHC 3+, or IHC 2+ and ISH-positive, with no prior chemotherapy or HER2-targeted therapy for advanced disease. One line of endocrine therapy is allowed. Central-lab confirmation is required.
Intervention: Several randomized arms: HLX22 plus HLX87, HLX87 plus pertuzumab, trastuzumab deruxtecan plus pertuzumab, or docetaxel with trastuzumab and pertuzumab.
Recruiting status: Recruiting. Status verified 2026-03. The study start on the record is 27 February 2026.
Countries / sites: The location module listed one recruiting facility: Cancer Hospital, Chinese Academy of Medical Sciences, Beijing.
Last verified: 3 October 2026, from the ClinicalTrials.gov study record.
What it does not mean: HER2-positive disease does not create a seat. Randomization does not promise HLX22 or HLX87. One Beijing site is not a national program. ParkMega does not offer that hospital as a trial referral. The China treatment page already left CAMS off the booking route.

NCT05950945, DESTINY-Breast15

Phase: Phase 3. The official title describes a phase 3b open-label study.
Population: Unresectable or metastatic breast cancer that is HER2-low or HER2 IHC 0, either hormone-receptor-positive or hormone-receptor-negative. The record excludes people whose cancer was previously HER2-positive and people previously treated with anti-HER2 therapy in the metastatic setting.
Intervention: Trastuzumab deruxtecan.
Recruiting status: Recruiting. Status verified 2026-06. Record updated 2026-06-12.
Countries / sites: Recruiting locations included China, the United States, Belgium, Brazil, Ireland, Italy, the Netherlands, Portugal, and Spain. China sites marked recruiting included Sun Yat-sen University Cancer Center in Guangzhou, Beijing Hospital, and others.
Last verified: 3 October 2026, from the ClinicalTrials.gov study record.
What it does not mean: Trastuzumab deruxtecan is already approved for some HER2-low uses. This study is still a trial in the group the protocol defines. HER2-low and HER2 IHC 0 are not HER2-positive. A recruiting line for Sun Yat-sen University Cancer Center is a registry fact. It is not a ParkMega referral, and the hospital guide is not an enrollment path.

Registered, and not a seat

These phase 3 records were also opened on 3 October 2026. Each one was active and not recruiting. A famous name is not an open slot.

Record	Status on the registry	Status verified
NCT05514054, EMBER-4	Active, not recruiting	2026-04
NCT04964934, SERENA-6	Active, not recruiting	2026-09
NCT05132582, HER2CLIMB-05	Active, not recruiting	2026-09
NCT05629585, TROPION-Breast03	Active, not recruiting	2026-06
NCT05382299, ASCENT-03	Active, not recruiting	2026-04
NCT05382286, ASCENT-04	Active, not recruiting	2025-09

Are there clinical trials for HER2-positive breast cancer?

Yes. They are written for HER2-positive disease, usually IHC 3+ or IHC 2+ with a positive in situ hybridization test, and they add their own limits on prior HER2 treatment. NCT07294508 is one recruiting phase 2/3 example for previously untreated recurrent or metastatic HER2-positive disease. HER2-low studies such as DESTINY-Breast15 exclude prior HER2-positive results. The two labels are not interchangeable. Approved HER2 drugs are tracked on the approvals page.

Are there clinical trials for triple-negative breast cancer?

Yes, in more than one setting. NCT06926868 is a recruiting study for previously untreated metastatic or locally advanced disease when anti-PD-1 or anti-PD-L1 treatment is not suitable. NCT06393374 is a recruiting adjuvant study for residual disease after neoadjuvant therapy. Triple-negative disease is also the setting where approved immunotherapy has a role, which is a different fact and is explained on the immunotherapy page.

Are there clinical trials for hormone-receptor-positive breast cancer?

Yes. NCT06058377 is recruiting for stage II–III hormone-receptor-positive, HER2-negative disease selected with a genomic assay. NCT06982521 is recruiting for PIK3CA-mutant, hormone-receptor-positive, HER2-negative advanced disease after a CDK4/6 inhibitor. Hormone-receptor-positive disease is not one trial, and it is not the triple-negative immunotherapy path.

Metastatic breast cancer trials

Metastatic studies still split by subtype, by line of therapy, and by biomarker. A first metastatic treatment and a later line are different protocols. NCT06926868, NCT06982521, NCT07294508, and NCT05950945 are metastatic or unresectable examples, and each one has its own prior-treatment rule.

Can I join a trial after previous treatments failed?

Sometimes the protocol is written for that situation, and sometimes prior treatment is the reason a person is excluded. NCT06982521 requires progression on or after a CDK4/6 inhibitor. NCT07294508 excludes prior chemotherapy and prior HER2-targeted therapy for advanced disease. Failure of the last regimen is not a general entry rule.

Biomarker-selected trials

A biomarker-selected trial enrolls people with a defined test result. The examples above use ER and PR percentage, HER2 IHC and ISH, a MammaPrint High 2 result, a PIK3CA mutation, and a rule about who is not a candidate for PD-1 or PD-L1 treatment. The test has to match the assay and the cutoff in the protocol. A commercial gene-panel printout does not replace that.

HER2-positive, HER2-low, and HER2 IHC 0 are three different selection keys. The approvals page keeps the labelled uses. This page keeps the open-study question.

Are breast cancer clinical trials available in China?

Yes. Trials are registered with sites in China. On 3 October 2026, the ClinicalTrials.gov query for recruiting breast-cancer studies with a China location returned 654 records. Records read in full for this page include NCT06926868, with several China sites marked recruiting, NCT07294508, with one Beijing site marked recruiting, and NCT05950945, with Sun Yat-sen University Cancer Center in Guangzhou marked recruiting.

A Chinese registry number was not used. No ChiCTR record was status-checked in this pass, so none is cited.

Can foreign patients join clinical trials in China?

The records checked here do not say that a foreign patient can join. Four facts stay separate:

A trial can exist in China.
A named site can be marked recruiting.
That site can accept a foreign patient. The registry lines read for this page do not establish that.
ParkMega can have a verified referral. It does not, for these studies.

Breast cancer treatment in China is the routing page for a treatment file. Fudan University Shanghai Cancer Center and Sun Yat-sen University Cancer Center have hospital guides. Those guides are not enrollment paths. Fuda and Modern are not the sites named in the examples above, and they are not documented on the China treatment page as breast programs. A recruiting flag at Sun Yat-sen University Cancer Center on NCT05950945 does not change that.

Approved treatment compared with a clinical trial

Question	Approved treatment	Clinical trial
Regulatory status	A regulator has approved that drug for a defined indication.	The protocol’s question is still research, including when the question is a new use.
Evidence	Mature enough that a label or a guideline can name the use.	Still being collected. The study can later show benefit, no benefit, or harm.
Eligibility	The indication plus the treating clinician’s judgment.	The protocol’s inclusion and exclusion criteria.
Uncertainty	Known risks from the label, plus the person’s own health.	Those risks, plus the uncertainty the study is built to measure.
Availability	Depends on approval, stock, and the hospital.	Depends on an open site and a current screening status.
Cost and payment	Usual billing, insurance, and hospital rules.	The sponsor may cover the study product and research tests. Routine care, travel, and care outside the protocol can still be billed.
Monitoring	Usual clinical follow-up.	Protocol visits and research tests, along with usual care.
Consent	Consent for treatment.	A study consent that explains the design, the risks, and the right to leave.

A drug can be approved for one breast-cancer indication and experimental in another. Trastuzumab deruxtecan in NCT05950945 is the clear example: an approved drug, inside a trial, for a defined HER2-low or IHC 0 group. A trial that uses an approved drug is not automatically standard care.

Does joining a clinical trial mean I will receive the new treatment?

No. Several of the studies above assign people at random. The comparator may be usual chemotherapy, an approved combination, or another study arm. Some studies give the study drug to everyone who enrolls. The protocol states the design. This page cannot place someone on an arm, and screening is not enrollment.

Are clinical trials free?

No promise of free care should be made from a registry page.

Do breast cancer clinical trials cost money?

They can. The National Cancer Institute separates research costs from routine patient-care costs. A sponsor often pays for the investigational product and for tests done only because of the study. Clinic visits, scans, and treatments that a person would receive even outside the study are often billed to the patient or the insurer. Travel, accommodation, translation, and visa costs are a third group. The consent form and the site say which group a charge falls into.

Do trials pay for treatment?

Some pay for the study treatment. They do not automatically pay for all breast-cancer care, for drugs in a comparator arm, or for treatment at a hospital that is not a study site.

Can international patients join for free?

Nothing on this page supports that. A recruiting site in China, the United States, or anywhere else can still bill routine care. Home insurance may refuse care delivered in another country. ParkMega does not pay trial costs and does not offer free study treatment.

What records are needed to check trial eligibility?

A trial team usually needs the documents below before it can say whether screening is even worth opening. Gather them for a clinician or a study coordinator. Do not paste them into this website. The case-review control on this page does not store the file, and analytics on this site are not allowed to carry diagnosis, receptors, mutations, or eligibility answers.

Pathology report
Estrogen receptor result
Progesterone receptor result
HER2 result, including the test method and the score
Stage
Metastatic sites, if any
Prior surgery
Radiation
Chemotherapy
Endocrine therapy
Targeted therapy
Immunotherapy
Molecular or genomic tests, when they exist
Recent imaging
Recent laboratory results
Treatment dates
Progression dates, when the disease has grown through a treatment

The study may also ask for performance status and organ-function labs that are newer than the ones in the file. Missing a document is a reason to pause, not a reason to guess eligibility.

In this cluster

Questions people ask

What are clinical trials for breast cancer?

They are research studies that test a treatment, combination, sequence, or strategy in a defined group. A matching diagnosis does not mean someone can join, and an experimental option is not automatically better care.

Who qualifies for a breast cancer clinical trial?

The study team decides, using that protocol. Stage, subtype, biomarkers, prior treatment, current disease, organ function, performance status, location, and the trial’s own rules can all matter.

Are clinical trials only for metastatic breast cancer?

No. Early-stage and locally advanced studies exist. Metastatic disease is neither required for every trial nor enough for a metastatic trial.

How do I find a clinical trial for my breast cancer subtype?

Use the pathology report and a registry such as ClinicalTrials.gov. Filter for the subtype and for recruiting status, then read the eligibility text. This site does not publish a separate URL for each subtype.

Are there clinical trials for HER2-positive breast cancer?

Yes. NCT07294508 was recruiting on the 3 October 2026 check for previously untreated recurrent or metastatic HER2-positive disease. HER2-low trials are a different group.

Are there clinical trials for triple-negative breast cancer?

Yes. NCT06926868 and NCT06393374 were recruiting on that check, one in a metastatic or locally advanced setting and one after residual disease at surgery.

Are there clinical trials for hormone-receptor-positive breast cancer?

Yes. NCT06058377 was recruiting for selected stage II–III hormone-receptor-positive, HER2-negative disease, and NCT06982521 was recruiting for PIK3CA-mutant advanced disease after a CDK4/6 inhibitor.

Can I join a trial after previous treatments failed?

Only if that protocol allows the prior treatment. Some studies require progression after a named drug class. Others exclude people who already received chemotherapy or HER2-targeted therapy for advanced disease.

Are breast cancer clinical trials available in China?

Yes. A ClinicalTrials.gov search on 3 October 2026 returned 654 recruiting breast-cancer records with a China location. A record is not an open seat at every Chinese hospital.

Can foreign patients join clinical trials in China?

The records read for this page do not say so. A China site, a recruiting flag, and a ParkMega referral are different facts. ParkMega has no verified referral into the studies named here.

Does joining a clinical trial mean I will receive the new treatment?

No. Many trials assign people at random to the study approach or to another arm. The protocol states the design. Joining is the study team’s decision, not this page’s.

Are clinical trials free?

No. A sponsor may pay for the study product and research tests. Routine care, travel, accommodation, and international-patient costs can still be billed. Free care is not offered here.

What records are needed to check trial eligibility?

Pathology, ER, PR, HER2, stage, metastatic sites, prior surgery, radiation, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, molecular tests, recent imaging, recent labs, treatment dates, and progression dates when relevant.

Sources

NCI, Cancer Clinical Trials. What a trial is, and why an experimental approach is still a question.
NCI, Paying for Clinical Trials. Research costs, routine-care costs, and costs the sponsor may not cover.
ClinicalTrials.gov, NCT06926868. Status verified 2026-07. Read 3 October 2026.
ClinicalTrials.gov, NCT06393374. Status verified 2026-09. Read 3 October 2026.
ClinicalTrials.gov, NCT06058377. Status verified 2026-08. Read 3 October 2026.
ClinicalTrials.gov, NCT06982521. Status verified 2026-07. Read 3 October 2026.
ClinicalTrials.gov, NCT07294508. Status verified 2026-03. Read 3 October 2026.
ClinicalTrials.gov, NCT05950945. Status verified 2026-06. Read 3 October 2026.
ParkMega, breast cancer treatment. Established-care map. Not a trial list.
ParkMega, breast cancer treatment in China. Hospital guides are not trial referrals.

Evidence check: 3 October 2026. Sponsor-reported status can change. Confirm the live registry record and the site before anyone travels.

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