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Efficacy of neoadjuvant sacituzumab govitecan versus standard drug combination in patients with endocrine non‑responsive ER+/HER2‑negative early breast cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on patients with endocrine non‑responsive ER+/HER2‑negative early breast cancer. This form of breast cancer is found at an early stage, has cells that contain estrogen receptors (ER+) but do not shrink when hormone therapy is used, and lacks excess HER2 protein. The study tests a new medicine called sacituzumab govitecan, which is given by infusion (a drip into a vein). The treatment is used in a neoadjuvant setting, meaning it is given before surgery to try to reduce the size of the tumor.

The purpose is to determine whether the new drug works better than the usual chemotherapy regimen. Participants are assigned by chance to one of two groups: one group receives the new drug, and the other group receives the standard chemotherapy drugs paclitaxel, cyclophosphamide, epirubicin hydrochloride and docetaxel, all given by infusion. After several weeks of treatment, surgery is performed and the amount of remaining cancer is examined to see if a complete disappearance, called pathologic complete response, has been achieved. Follow‑up continues to monitor for any return of disease.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Eligibility Confirmation and Baseline Assessments

    After joining the study, you will undergo tests to confirm that the cancer is ER+ (estrogen receptor positive) and HER2‑negative, and that it does not respond to hormone therapy.

    Baseline measurements may include blood work, imaging scans, and a review of your medical history to establish a starting point for the trial.

  2. Step 2

    Randomization to Treatment Group

    You will be assigned by chance to one of two groups: the experimental group receiving sacituzumab govitecan or the standard‑of‑care group receiving conventional chemotherapy drugs.

    The assignment is done by the study system and you will not know the other group’s treatment.

  3. Step 3

    Start of Neoadjuvant Therapy

    Neoadjuvant therapy means treatment given before surgery to shrink the tumor.

    If you are in the experimental group, you will receive an infusion of sacituzumab govitecan at a dose of 10 mg per kilogram of body weight.

    If you are in the standard‑of‑care group, you will receive infusions of the following chemotherapy agents:

    paclitaxel 80 mg per square meter, cyclophosphamide 600 mg per square meter, epirubicin hydrochloride 90 mg per square meter, and docetaxel 100 mg per square meter.

    Each medication is given by intravenous infusion, as described in the study protocol.

  4. Step 4

    Repeated Treatment Cycles

    The infusions are repeated for multiple cycles according to the schedule defined by the study protocol.

    The same dose and route are used for each cycle, and the total number of cycles is determined by the investigators before the trial begins.

  5. Step 5

    Safety Monitoring and Laboratory Tests

    During each cycle you will have regular check‑ups to monitor how you are feeling and to detect any side effects.

    Blood samples will be taken to evaluate organ function and to ensure the medication levels are safe.

    Any adverse reactions will be recorded and managed according to the study guidelines.

  6. Step 6

    Completion of Neoadjuvant Therapy

    After the final cycle, you will stop receiving the study medication and will be prepared for surgery.

    Your doctors will review the results of the treatment and plan the timing of the operation.

  7. Step 7

    Surgical Removal of Tumor

    You will undergo surgery to remove the breast tumor and surrounding tissue.

    The surgical specimen will be examined to determine whether a pathological complete response (pCR) has been achieved.

  8. Step 8

    Pathology Evaluation and Outcome Assessment

    Pathologists will assess the tissue for residual cancer burden (RCB) and record the presence or absence of cancer cells.

    These findings are the primary and secondary endpoints of the study.

  9. Step 9

    Long‑Term Follow‑Up

    After surgery you will attend scheduled follow‑up visits to monitor for disease recurrence and overall health.

    The study will track long‑term outcomes such as event‑free survival, invasive disease‑free survival, invasive breast cancer‑free survival, distant recurrence‑free survival, and overall survival.

Who can join the trial?

11 criteria

  • Provide a signed informed consent form before any study‑specific tests or procedures that are not part of your regular care.
  • Be 18 years of age or older at the time you sign the consent form; both women and men are eligible.
  • Have a confirmed diagnosis of invasive breast cancer on one side of the breast that is stage IIA, IIB, or III (meaning the tumor is larger or has spread to nearby lymph nodes), and the tumor must be hormone‑receptor positive (more than 10 % of cells show estrogen‑receptor staining) and HER2‑negative (tests show low HER2 protein levels). If there are multiple tumors in the same breast, each must meet these same requirements.
  • Have an ECOG performance status of 0 or 1, which means you are fully active (0) or able to do light work but are unable to carry out physically demanding activities (1).
  • If you are a woman who could become pregnant, you must have a negative urine or blood pregnancy test within the 28 days before joining the study, and you must use highly effective birth control methods (such as a sterilization procedure, a non‑hormonal IUD plus a condom, or complete abstinence) during treatment and for at least 6 months after the last dose. Men with partners who could become pregnant must use similar contraception for at least 3 months after the last dose.
  • Show adequate blood and organ function, which includes:
    • Enough white blood cells (neutrophils) – at least 1.5 × 10⁹ per liter.
    • Platelet count of at least 100 × 10⁹ per liter (helps blood clot).
    • Hemoglobin level of at least 100 g/L (shows you are not anemic).
    • Liver enzymes (AST, ALT, alkaline phosphatase) no more than 2.5 times the normal upper limit.
    • Bilirubin (a liver waste product) no more than 1.5 times the normal limit, or up to 3 times if you have Gilbert’s syndrome.
    • Kidney function within normal range, measured by serum creatinine or a creatinine clearance/eGFR of at least 60 mL/min.

Who cannot join the trial?

15 criteria

  • Having cancer that has spread to other parts of the body (called metastatic) or is locally advanced and cannot be treated with surgery or radiation aimed at cure.
  • Having received any chemotherapy, hormone therapy, or other investigational drugs for invasive breast cancer before joining the study.
  • Not willing to have a small tissue sample taken (a biopsy) after a short period of hormone treatment to check how the tumor responds.
  • Having a tumor that cannot be removed by surgery, as judged by a qualified doctor.
  • Having a history of any other cancer, unless it was a non‑invasive breast cancer, a completely removed non‑melanoma skin cancer, or another cancer that has been disease‑free for at least five years and is considered low risk.
  • Being pregnant or breastfeeding.
  • Having a known severe allergy (hypersensitivity) or a medical reason that makes it unsafe to receive the study drug or any of its ingredients.
  • Having had major surgery within the past 28 days or not having recovered fully from major side effects after surgery.
  • Having serious medical or mental health conditions that could affect safety or the ability to give informed consent, such as active inflammatory bowel disease (like ulcerative colitis or Crohn’s disease), serious infections needing antibiotics, moderate to severe heart failure (NYHA class II–IV), unstable chest pain (unstable angina), recent heart attack, or dangerous heart rhythm problems.
  • Having a known HIV infection with a detectable amount of virus in the blood (known as a detectable viral load).
  • Having an active or past hepatitis B or C infection, identified by the presence of hepatitis B surface antigen (HBsAg), hepatitis B DNA, or hepatitis C RNA in the blood.
  • Having a weakened immune system (immunodeficiency) or taking high‑dose steroids (equivalent to 20 mg or more of prednisone per day) or other medicines that suppress the immune system within 14 days before joining the study; occasional low‑dose or topical steroids are allowed.
  • Using any external hormone medicines, such as birth control pills, hormone replacement therapy, or other hormone treatments, except for low‑dose topical hormone products like vaginal estrogen cream.
  • Having previously been treated with drugs called topoisomerase 1 inhibitors, which are a type of chemotherapy.
  • Being enrolled at the same time in another clinical trial that tests a new treatment for the same purpose, or in any other trial that uses an investigational therapeutic product.
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Investigated drugs

  • Paclitaxel

    is a chemotherapy drug given by infusion. In this study it is part of the standard treatment that patients receive before surgery. It works by stopping cancer cells from dividing, helping to shrink the tumor.

  • Cyclophosphamide

    is another chemotherapy medicine given through an IV infusion. It is used as part of the standard care in the trial. The drug damages the DNA of cancer cells, which can stop them from growing.

  • Sacituzumab Govitecan

    (brand name Trodelvy) is the experimental therapy being tested. It is given as an infusion and is designed to target a protein found on many breast cancer cells. By attaching to this protein, the drug delivers a chemotherapy payload directly to the cancer, aiming to kill the tumor more effectively.

  • Epirubicin hydrochloride

    is a chemotherapy agent administered by infusion. It is included in the standard treatment arm of the trial. The medication interferes with the DNA inside cancer cells, helping to reduce tumor size.

  • Docetaxel

    is a chemotherapy drug delivered through an IV infusion. It is also part of the standard care regimen in the study. Docetaxel works by preventing cancer cells from dividing, which can lead to tumor shrinkage.

What is already known about the treatment

  • Paclitaxel

    Paclitaxel is given by intravenous infusion, where the drug is slowly dripped into a vein. It is an approved chemotherapy medicine widely used in breast, ovarian and lung cancers. It works by binding to microtubules inside cells, keeping them stable so cancer cells cannot divide. Paclitaxel belongs to the taxane class of anticancer agents.

  • Cyclophosphamide

    Cyclophosphamide is administered by intravenous infusion into a vein. It is an approved alkylating chemotherapy drug used for many cancers, including breast cancer and lymphomas. Inside the body it is changed into an active form that adds alkyl groups to DNA, causing the DNA strands to break and the cancer cell to die. Cyclophosphamide is classified as an alkylating agent.

  • Sacituzumab Govitecan

    Sacituzumab govitecan is supplied as a powder that is mixed to make a solution for intravenous infusion. It is an approved antibody‑drug conjugate for metastatic triple‑negative breast cancer and is now being studied for early ER‑positive, HER2‑negative breast cancer. The antibody part seeks out the Trop‑2 protein on cancer cells and delivers the chemotherapy payload SN‑38 directly to those cells, helping to kill them while sparing normal tissue. It is classified as an antibody‑drug conjugate.

  • Epirubicin Hydrochloride

    Epirubicin hydrochloride is given by intravenous infusion into a vein. It is an approved anthracycline chemotherapy used mainly for early breast cancer and other solid tumors. The drug inserts itself between DNA base pairs and blocks an enzyme called topoisomerase II, leading to DNA damage and cancer‑cell death. Epirubicin belongs to the anthracycline class of anticancer drugs.

  • Docetaxel

    Docetaxel is administered by intravenous infusion. It is an approved taxane chemotherapy used for breast, lung, prostate and other cancers. It encourages the formation of stable microtubules and prevents their breakdown, which stops cancer cells from dividing. Docetaxel is classified as a taxane anticancer agent.

Investigated diseases

Endocrine non‑responsive estrogen receptor‑positive, HER2‑negative early breast cancer – This disease is an early‑stage breast cancer that grows in response to estrogen but lacks overexpression of the HER2 protein. The tumor does not shrink or stop growing when hormone‑blocking therapies are used. As a result, cancer cells continue to proliferate despite endocrine treatment. Over time, the disease can advance to larger tumors or spread to nearby lymph nodes if not controlled.
Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IITrial ID2025-520759-10-00Protocol codeABCSG 64Estimated enrolment80 patientsSponsorVerein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group

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