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Triple Negative Breast Cancer Clinical Trials

We surface trials from the U.S. National Library of Medicine with plain-English explanations of what each trial is actually testing. Whether you have early-stage, locally advanced, or metastatic triple negative breast cancer — knowing your treatment options and available trials is the first step.

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Data sourced from the U.S. National Library of Medicine. Plain-English summaries are AI-generated to help you understand — always verify with your medical team.

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Key Factors

Understanding Triple Negative Breast Cancer trial markers

Triple Negative Breast Cancer is defined by the absence of three key receptors: HER2, ER, and PR. Other molecular markers including PD-L1, BRCA status, and immune cell infiltration determine prognosis and trial eligibility. Your pathology report and tumor molecular profile are essential for matching to the right trials.

HER2/ER/PR Status
Defining criterion (all negative)
TNBC is defined by all three receptors being negative: HER2 (0 or 1+), ER negative, and PR negative. This defining criterion eliminates hormone therapy and HER2-targeted therapy options, requiring alternative treatment strategies. Confirmed by immunohistochemistry on tumor tissue.
PD-L1 Expression
Variable, 30-50%
PD-L1 is a protein that suppresses immune response. Testing PD-L1 expression predicts immunotherapy benefit. PD-L1 positive TNBC (30-50%) shows better response to checkpoint inhibitors combined with chemotherapy. Guides treatment selection in many trials.
BRCA1/2 Mutation Status
15-20% TNBC
BRCA1 or BRCA2 mutations present in 15-20% of TNBC patients. BRCA-mutant TNBC is eligible for PARP inhibitor therapy (olaparib, talazoparib) which significantly improves survival. Test via blood or tumor tissue. Has therapeutic and hereditary implications.
TNM Stage
Variable
TNM staging (Tumor size, Node involvement, Metastasis) determines treatment intensity and trial eligibility. Early-stage TNBC (Stage I-II) often receives aggressive neoadjuvant chemotherapy. Metastatic TNBC requires palliative systemic therapy strategies.
Ki-67 Proliferation Index
High, ≥30%
Measures percentage of rapidly dividing cells. TNBC typically has high Ki-67 (≥30%) indicating aggressive biology. Predicts response to chemotherapy and need for intensive multimodal therapy. Helps prognostication and guides treatment selection.
Lymphocyte Infiltration (TIL)
Variable
Tumor-infiltrating lymphocytes (TIL) represent immune cell presence in the tumor. High TIL indicates robust immune response and predicts better outcome with immunotherapy. Variable in TNBC. Some trials stratify patients by TIL levels for personalized treatment.
Not sure which biomarkers you have? Upload your pathology or genomic report. We'll read it and match you to recruiting trials →
From patients like you

Common questions about Triple Negative Breast Cancer trials

Triple Negative Breast Cancer (TNBC) is a subtype where cancer cells lack three key receptors: HER2 (human epidermal growth factor receptor 2), ER (estrogen receptor), and PR (progesterone receptor). This accounts for 10-15% of all breast cancers. TNBC tends to be more aggressive and grows faster than other subtypes, but recent immunotherapy advances have significantly improved treatment options.

Key characteristics: All three receptors are negative on pathology testing. Faster growth and earlier spread compared to hormone receptor-positive cancers. Doesn't respond to hormone therapy or HER2-targeted therapies. Requires chemotherapy-based and immunotherapy-based approaches.

Prevalence: ~10-15% of all breast cancers. More common in younger women, African American women, and BRCA1 mutation carriers. Can occur at any stage from early-stage to metastatic disease.

Modern treatment outlook: With chemotherapy plus immunotherapy, early-stage TNBC outcomes have improved significantly. Pathologic complete response (pCR) to neoadjuvant therapy predicts better long-term survival. New agents targeting TNBC continue to emerge.

If you have TNBC, knowing your stage, PD-L1 status, and BRCA status guides treatment selection and trial eligibility.

TNBC diagnosis requires pathology testing showing all three receptors are negative:

1. HER2 Testing (IHC and/or FISH): Immunohistochemistry (IHC) scores HER2 protein 0, 1+, 2+, or 3+. For TNBC, HER2 must be 0 or 1+ (negative). IHC 2+ may require FISH to confirm negative status. FISH measures HER2 gene copies; negative result confirms TNBC.

2. Estrogen Receptor (ER) Testing: Tests for ER protein presence. Must be negative (≤1%) to qualify as TNBC. Scored as positive if ≥1%.

3. Progesterone Receptor (PR) Testing: Tests for PR protein presence. Must be negative (≤1%) to qualify as TNBC. Scored as positive if ≥1%.

Criteria for TNBC: HER2 negative (IHC 0-1+ OR FISH negative), AND ER negative, AND PR negative.

Timing: Tested at initial diagnosis on biopsy or surgical specimen. All three receptors are reported on the pathology report. Get a copy of your pathology report—you'll need it for trial enrollment.

Important: Ensure your pathology report explicitly states the status of all three receptors before enrolling in any TNBC trial.

TNBC tends to be more aggressive for several biological reasons:

  • No hormone receptors: Hormone therapy (tamoxifen, aromatase inhibitors) doesn't work because cancer cells lack ER and PR. Hormones that stop other breast cancers have no effect on TNBC.
  • No HER2 targets: HER2-targeted therapies like trastuzumab (Herceptin) don't apply. TNBC cells don't have HER2 to target, eliminating this treatment option.
  • Faster growth: TNBC cells often divide and grow faster than hormone receptor-positive cancers, leading to quicker progression if untreated.
  • Earlier spread: TNBC is more likely to spread to lymph nodes and distant organs earlier in disease course compared to other subtypes.
  • Higher grade: TNBC tumors are more likely to be high grade (aggressive-appearing under microscope) with high Ki-67 (fast-dividing cells).

Treatment implications: Requires chemotherapy-based approaches across all stages. Hormone therapy and HER2-targeted therapy aren't options. Newer immunotherapy and PARP inhibitor approaches have significantly improved outcomes in recent years.

TNBC treatment is based on chemotherapy, with newer approaches including immunotherapy and PARP inhibitors:

  • Chemotherapy (backbone of treatment): Anthracycline-based (doxorubicin) + cyclophosphamide, followed by taxane-based (paclitaxel). Given neoadjuvant (before surgery) and adjuvant (after surgery) in early-stage. Ongoing in metastatic disease.
  • Immunotherapy: Checkpoint inhibitors (pembrolizumab, atezolizumab, durvalumab) combined with chemotherapy. Approved for early-stage TNBC and metastatic PD-L1+ TNBC. Unleashes immune system to attack cancer.
  • PARP inhibitors: Olaparib (Lynparza), talazoparib (Talquetamab) for BRCA-mutant TNBC. Block DNA repair mechanisms. Significantly improve survival in BRCA-mutant disease.
  • Novel agents in trials: New immunotherapy combinations, targeted therapies, and CDK inhibitors being tested specifically for TNBC.

Treatment selection depends on: Cancer stage (early vs. metastatic), PD-L1 status, BRCA status, prior treatments, overall health. Clinical trials offer access to newer combinations and agents.

Many TNBC trials test chemotherapy + immunotherapy combinations, PARP inhibitors, and novel mechanisms to improve outcomes and reduce side effects.

Chemotherapy is the cornerstone of TNBC treatment across all stages:

Early-stage TNBC: Chemotherapy is essential. Neoadjuvant chemotherapy (before surgery) shrinks tumors, improves surgical outcomes, and predicts prognosis. Anthracycline (doxorubicin) + cyclophosphamide followed by taxane (paclitaxel). Pathologic complete response (pCR—no cancer cells found at surgery) predicts better long-term survival.

Metastatic TNBC: Ongoing chemotherapy continues as long as it's effective. Combination chemotherapy often given first-line, with newer agents (immunotherapy, PARP inhibitors) added or used subsequently depending on response and BRCA/PD-L1 status.

Standard regimens: AC-T (doxorubicin + cyclophosphamide → taxane) most common. Paclitaxel given weekly or docetaxel every 3 weeks. Duration 12-24 weeks typically.

Side effects: Fatigue, nausea, hair loss, low blood counts, hand-foot syndrome. Mostly manageable with supportive care and can resolve after treatment ends.

Combination approaches: Many trials combine chemotherapy with immunotherapy from the start, which improves outcomes beyond chemotherapy alone.

Immunotherapy (checkpoint inhibitors) is now standard for many TNBC patients:

  • Pembrolizumab (Keytruda): Anti-PD-1 checkpoint inhibitor. Approved combined with chemotherapy for early-stage TNBC (KEYNOTE-522 trial). Also approved for metastatic TNBC. Given IV every 3 weeks.
  • Atezolizumab (Tecentriq): Anti-PD-L1 checkpoint inhibitor. Approved with chemotherapy (nab-paclitaxel) for metastatic PD-L1+ TNBC (IMpassion031 trial). Given IV every 3 weeks.
  • Durvalumab (Imfinzi): Anti-PD-L1 checkpoint inhibitor. In trials for TNBC, particularly in early-stage after chemotherapy.
  • How immunotherapy works: Checkpoint inhibitors block brakes on the immune system, allowing T cells to recognize and attack cancer cells. Particularly effective in TNBC which often has high immune cell infiltration.

Eligibility considerations: PD-L1 status (positive in 30-50% of TNBC) guides selection. Trials often stratify by PD-L1 status. Some work in PD-L1 negative disease too.

Side effects: Immune-related adverse events (irAE)—colitis, pneumonitis, thyroid problems, skin rash. Usually manageable with steroids or discontinuation if severe.

Immunotherapy represents major advance for TNBC, improving survival over chemotherapy alone.

PD-L1 is a protein that suppresses the immune system. It's important for understanding immunotherapy benefit in TNBC:

What is PD-L1? Programmed death ligand 1 (PD-L1) is a protein found on cancer cells and immune cells. It acts as a "brake" on the immune system, preventing T cells from attacking cancer.

PD-L1 testing: Measured by immunohistochemistry on tumor tissue. Reported as percentage of cancer cells expressing PD-L1. Threshold varies (1%, 10%, 50%) depending on clinical context and trial. Present in 30-50% of TNBC.

Why it matters for treatment: PD-L1 positive TNBC predicts better response to checkpoint inhibitors (pembrolizumab, atezolizumab). These drugs block PD-L1, removing the immune brake and allowing T cells to attack cancer.

Clinical implications: Many trials stratify patients by PD-L1 status. Some checkpoint inhibitors approved specifically for PD-L1+ metastatic TNBC. Even PD-L1 negative TNBC may benefit from immunotherapy in combination approaches.

Important: Make sure your pathology report includes PD-L1 status testing. Needed for trial eligibility assessment and treatment selection.

Yes, BRCA testing is strongly recommended for all TNBC patients:

Why test for BRCA? 15-20% of TNBC patients carry BRCA1 or BRCA2 mutations. BRCA testing identifies patients eligible for PARP inhibitor therapy (olaparib, talazoparib) which significantly improves survival. Also helps identify hereditary cancer risk in family members.

How to get tested: Can be done via blood test or testing tumor tissue from biopsy/surgery. Genetic counseling recommended before and after testing. Some oncologists order it, or ask your doctor for referral to genetic counselor.

Timing: Can be done at any point—at diagnosis or later. Ideally before starting treatment so BRCA status informs treatment selection.

Clinical implications if BRCA positive: Eligible for PARP inhibitor maintenance therapy after chemotherapy in early-stage disease. First-line PARP inhibitors approved for metastatic BRCA-mutant TNBC. Many trials stratify by BRCA status.

If BRCA negative: Standard chemotherapy and immunotherapy approaches. May still be eligible for trials testing novel BRCA-independent approaches.

Insurance: Most insurance covers BRCA testing for TNBC patients. Check with your insurance first.

Clinical trials offer significant benefits for TNBC patients:

  • Access to cutting-edge therapies: Newer immunotherapy combinations, PARP inhibitors, and novel agents not yet available outside trials. Potentially more effective than standard treatment.
  • Potential for better outcomes: Many TNBC trials show improved survival compared to standard treatment. Access to therapies that may work better for your specific tumor characteristics (PD-L1+, BRCA-mutant).
  • Close medical monitoring: Frequent exams, labs, and imaging catch side effects early and monitor response closely. More oversight than routine clinical care.
  • Contribute to medical advancement: Help researchers develop better TNBC treatments for future patients. Part of scientific discovery process.
  • Financial coverage: Trial covers cost of experimental drug and study-related tests. Drug sponsors cover most trial expenses.
  • Flexible care: Some trials offer additional support services, nutritional counseling, or mental health resources.

Potential considerations: Time commitment, possible side effects, may receive standard treatment in randomized trials. But overall benefits often outweigh risks, particularly in early-stage TNBC.

Each TNBC trial has specific eligibility criteria. Common requirements include:

Essential criteria:

  • Confirmed TNBC diagnosis (all three receptors negative: HER2-, ER-, PR-)
  • Age typically 18+ (varies by trial)
  • Adequate organ function (heart, kidney, liver—measured by blood tests)
  • ECOG performance status 0-2 (able to perform daily activities)
  • No active secondary cancers

May vary by trial:

  • Stage (early-stage, locally advanced, or metastatic)
  • Prior treatments (treatment-naive vs. previously treated)
  • Specific biomarkers (PD-L1+ vs. PD-L1-, BRCA status, lymphocyte infiltration)
  • Brain metastases (some trials exclude, others allow stable brain metastases)
  • Pregnancy/lactation status
  • HIV/hepatitis status

Your doctor and the trial team will determine final eligibility. Even if you don't perfectly match all criteria, it's worth asking—some trials have flexibility or may have related trials matching your situation.

Upload your pathology report and treatment history to find matching trials →

Side effects vary depending on drugs in trial. Common effects in TNBC trials:

From chemotherapy:

  • Fatigue (most common)
  • Nausea and vomiting
  • Hair loss
  • Low blood counts (anemia, infections, bleeding)
  • Hand-foot syndrome (redness, swelling of palms/soles)
  • Mouth sores

From immunotherapy (checkpoint inhibitors):

  • Immune-related adverse events (irAE): Colitis (diarrhea, abdominal pain), pneumonitis (cough, shortness of breath), thyroid dysfunction, endocrinopathies, rashes
  • Fatigue
  • Headache, joint pain
  • Infusion reactions (rare with modern protocols)

Management: Most chemotherapy side effects managed with anti-nausea meds, growth factors, hydration. Immune-related side effects usually managed with steroids or immunosuppressive drugs. Severe irAE may require trial discontinuation.

Support during trial: Trial team provides detailed side effect management protocols. Can adjust doses or add supportive medications. Close monitoring catches side effects early.

Ask trial coordinator for complete side effect profile and management plan before enrolling.

Treatment duration varies significantly by stage and response:

Early-stage TNBC:

  • Neoadjuvant chemotherapy (before surgery): 12-18 weeks (3-4 cycles of AC, then 12-16 weeks of taxane)
  • Surgery: 2-6 weeks recovery
  • Adjuvant chemotherapy (after surgery): May receive additional rounds if residual disease remains
  • Immunotherapy (if added): Often continues for 12-24 months depending on trial and response
  • Total active treatment: 6-12 months of chemotherapy ± immunotherapy

Metastatic TNBC:

  • Chemotherapy ± immunotherapy: continues as long as effective and tolerated
  • Can last months to years depending on response and side effects
  • May switch to different regimens if resistance develops

Clinical trials: Duration specified in protocol. Often 1-2 years of active treatment plus long-term follow-up.

After treatment ends: Regular follow-up with oncologist every 3-4 months. Imaging and labs to monitor for recurrence.

Your oncologist will discuss your specific timeline based on stage, response, and side effects.

TNBC prognosis has improved significantly with recent treatment advances:

Early-stage TNBC (Stage I-III):

  • With neoadjuvant chemotherapy: ~40-50% achieve pathologic complete response (pCR—no cancer at surgery)
  • Patients with pCR: excellent long-term outcome (~85% 5-year disease-free survival)
  • Residual disease after chemotherapy: worse prognosis but improved with newer adjuvant immunotherapy
  • Addition of immunotherapy improves survival: ~5-year disease-free survival approaches 80-85% with chemotherapy + immunotherapy

BRCA-mutant TNBC:

  • PARP inhibitors (olaparib) improve survival significantly compared to standard chemotherapy
  • BRCA-mutant patients have better prognosis than BRCA-wild-type TNBC

PD-L1+ TNBC:

  • Better response to immunotherapy combinations
  • Improved survival compared to standard chemotherapy alone

Metastatic TNBC:

  • Median overall survival 12-24 months historically, improving with new therapies
  • Immunotherapy combinations extending survival
  • BRCA+ metastatic TNBC with PARP inhibitors showing extended survival

Individual prognosis depends on stage, response to neoadjuvant therapy, BRCA status, PD-L1 expression, and access to newer treatments. Clinical trials offer access to cutting-edge therapies potentially improving your prognosis.

TNBC clinical trials are available nationwide and internationally.

Trial locations include:

  • Major cancer centers: Johns Hopkins, MD Anderson, Memorial Sloan Kettering, Mayo Clinic, UCSF, Stanford, UCSD
  • Academic medical centers: University hospitals across the US conducting breast cancer research
  • Community hospitals: Many smaller hospitals participate in cooperative group trials
  • Specialty breast cancer centers: Centers focused on breast cancer with TNBC expertise

Geographic distribution: Major concentrations in California, New York, Texas, Massachusetts. Rural areas may have fewer options, but growing availability.

Finding TNBC trials:

  • Use our search tool on this page—filter by location, phase, recruitment status
  • Search ClinicalTrials.gov directly (clinicaltrials.gov) for "Triple Negative Breast Cancer"
  • Ask your oncologist about TNBC trials they recommend
  • Contact TNBC advocacy organizations (TNBC Society, Susan G. Komen Foundation)

Traveling for trials: Some patients travel to major cancer centers. Ask trial coordinator about travel reimbursement, lodging partnerships, or telemedicine visit options.

Use our matching tool to find TNBC trials in your area or nationwide.

Joining a TNBC clinical trial through MyCancerTrialMatch is straightforward:

Step 1: Search TNBC trials

  • Browse our list of Triple Negative Breast Cancer trials
  • Use filters: phase, location (state), recruitment status (recruiting/not yet/active not recruiting)
  • Read trial summaries to find ones matching your stage and biomarkers

Step 2: Review trial details

  • Click on a trial to see full details: NCT ID, phase, locations, description
  • Review eligibility criteria carefully
  • Note any biomarker requirements (PD-L1, BRCA status, etc.)

Step 3: Check your eligibility

  • Click 'Check my eligibility' button on trials of interest
  • Upload your pathology report (confirms TNBC diagnosis and biomarkers)
  • Upload treatment history and medical records
  • Our AI analyzes your eligibility against trial criteria
  • Receive detailed eligibility assessment

Step 4: Contact the trial

  • Use contact info provided (phone, email, website link)
  • Call trial coordinator and express your interest
  • Discuss your eligibility and ask any questions
  • Arrange screening visit if you're a potential candidate

Step 5: Screening and enrollment

  • Attend screening visit for confirmatory tests
  • Review and sign informed consent document
  • Begin trial treatment

Save your favorite trials: Save trials to your account to review later or share with your oncologist.

Questions? Contact our patient advocate team for guidance.

Learn more

Knowledge Base

TNBC Basics

Triple Negative Breast Cancer Basics

Triple Negative Breast Cancer lacks all three key receptors: HER2, estrogen receptor (ER), and progesterone receptor (PR). This accounts for 10-15% of breast cancers. TNBC tends to grow faster and spread earlier than other subtypes, but recent immunotherapy advances have dramatically improved treatment options and survival rates.

Treatment Options

Understanding TNBC Treatment Options

TNBC treatment is based on chemotherapy combined with immunotherapy. Standard approach is anthracycline + taxane-based chemotherapy. Newer checkpoint inhibitors (pembrolizumab, atezolizumab) combined with chemotherapy improve outcomes significantly. BRCA-mutant TNBC also benefits from PARP inhibitors. Treatment plans personalized based on stage, PD-L1 status, and BRCA status.

Immunotherapy Role

The Role of Immunotherapy in TNBC

Immunotherapy is transforming TNBC treatment. Checkpoint inhibitors unleash the immune system to attack cancer cells, particularly effective in TNBC which often has high immune infiltration. Combined with chemotherapy, immunotherapy improves disease-free survival in early-stage TNBC. PD-L1 testing helps identify patients most likely to benefit. Many trials explore novel immunotherapy combinations.

Genetic Testing

BRCA Testing and Implications for TNBC

15-20% of TNBC patients carry BRCA1 or BRCA2 mutations. BRCA testing is strongly recommended and identifies patients eligible for PARP inhibitor therapy, which significantly improves survival. Testing can be done via blood or tumor tissue. Has therapeutic implications for treatment planning and hereditary implications for family members. Insurance usually covers testing for TNBC patients.

Supportive Care

Nutrition & Lifestyle During Treatment

Maintaining adequate nutrition, moderate exercise (with doctor approval), and managing stress support treatment tolerance and recovery. Working with oncology nutritionists and exercise specialists helps manage side effects. Staying connected with support groups, mental health resources, and TNBC patient communities is equally important during and after treatment.

Stage-Based Approach

TNBC by Stage and Treatment Approach

Treatment varies by stage. Early-stage TNBC benefits from aggressive neoadjuvant chemotherapy ± immunotherapy before surgery. Pathologic complete response (pCR) predicts excellent long-term outcomes. Metastatic TNBC requires ongoing systemic therapy tailored to biomarkers. Clinical trials offer newer combinations and agents for all stages, improving outcomes and potentially reducing side effects.

Real experiences

Patient Stories

From Aggressive Diagnosis to Immunotherapy Hope: Jennifer's TNBC Journey

Jennifer was diagnosed with Triple Negative Breast Cancer at 45. Her oncologist told her the diagnosis was aggressive and growth could be fast, which was initially frightening. However, she learned that TNBC responds well to chemotherapy and newer immunotherapy combinations. Through this platform, she found a Phase III trial testing pembrolizumab combined with chemotherapy.

"Learning about the immunotherapy trial gave me hope," Jennifer shares. "My doctor explained how checkpoint inhibitors work with my immune system to fight the cancer. The trial team was transparent about potential side effects but also about the benefits shown in early research. After chemotherapy and immunotherapy, my scans showed a complete response."

"I was in remission faster than standard treatment alone would have provided. Being in a trial made me feel like my case mattered and that I had access to the newest, most promising treatments. I encourage every TNBC patient to explore trials."

BRCA+ TNBC: Finding a Personalized Treatment Path

Andrea was 38 when diagnosed with TNBC. Genetic testing revealed she carried a BRCA1 mutation, which was both personally significant and therapeutically important. Her oncologist explained she qualified for a PARP inhibitor trial specifically designed for BRCA-mutant TNBC. Beyond the physical challenge, Andrea faced the emotional burden of learning about hereditary cancer risk in her family.

"Finding out I was BRCA+ changed everything," Andrea explains. "It meant I needed different treatment but also that I could access newer drugs specifically designed for my mutation. The trial gave me access to olaparib, which has shown remarkable efficacy in BRCA-mutant TNBC. My oncologist connected me with genetic counseling for family implications."

"Two years out, I'm in remission with manageable side effects. The trial gave me personalized treatment based on my genetics. I'm now advocating for other BRCA+ women to get tested and explore their options—both treatment and preventive care for family members."